maudesummary

	A	B	C	D	E	F	G	H
1	number_of_incidents	cfr_part_name	cfr_subpart_name	device_name	patient_outcome	facility_maintained	device_problem	facility
2	5575	PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES	Subpart B—Clinical Chemistry Test Systems	System, Test, Blood Glucose, Over The Counter	Life Threatening	Y		OTHER
3	4264			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y
4	3487	PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES	Subpart B—Clinical Chemistry Test Systems	System, Test, Blood Glucose, Over The Counter	Life Threatening	Y
5	2173	PART 878—GENERAL AND PLASTIC SURGERY DEVICES	Subpart E—Surgical Devices	Stapler, Surgical	Required Intervention	Y
6	2112	PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES	Subpart B—Clinical Chemistry Test Systems	System, Test, Blood Glucose, Over The Counter	Life Threatening	Y		NOT APPLICABLE
7	2042			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y	Leak
8	1990	PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES	Subpart B—Clinical Chemistry Test Systems	System, Test, Blood Glucose, Over The Counter	Required Intervention	Y
9	1694	PART 882—NEUROLOGICAL DEVICES	Subpart F—Neurological Therapeutic Devices	Shunt, Central Nervous System And Components	Required Intervention	Y
10	1499	PART 870—CARDIOVASCULAR DEVICES	Subpart F—Cardiovascular Therapeutic Devices	Automated External Defibrillators (Non-Wearable)	Death	Y
11	1382	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart F—Therapeutic Devices	System, Peritoneal, Automatic Delivery	Hospitilization	Y
12	1249			Ventricular (Assisst) Bypass	Required Intervention	Y	Other (for use when an appropriate device code cannot be identified)	HOSPITAL
13	1200	PART 878—GENERAL AND PLASTIC SURGERY DEVICES	Subpart E—Surgical Devices	Electrosurgical, Cutting & Coagulation & Accessories	Required Intervention	Y
14	1172			System, Endovascular Graft, Aortic Aneurysm Treatment	Hospitilization	Y
15	1143			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y	Other (for use when an appropriate device code cannot be identified)	HOSPITAL
16	1111	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart F—Therapeutic Devices	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Hospitilization	Y
17	1072	PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES	Subpart B—Clinical Chemistry Test Systems	System, Test, Blood Glucose, Over The Counter	Hospitilization	Y
18	985			System, Endovascular Graft, Aortic Aneurysm Treatment	Death	Y
19	941	PART 878—GENERAL AND PLASTIC SURGERY DEVICES	Subpart E—Surgical Devices	Stapler, Surgical	Required Intervention	Y		NOT APPLICABLE
20	909			Permanent Defibrillator Electrodes	Required Intervention	Y		HOSPITAL
21	818	PART 888—ORTHOPEDIC DEVICES	Subpart E—Surgical Devices	Orthopedic Manual Surgical Instrument	Required Intervention	Y
22	808	PART 870—CARDIOVASCULAR DEVICES	Subpart D—Cardiovascular Prosthetic Devices	System, Balloon, Intra-Aortic And Control	Required Intervention	Y
23	801	PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES	Subpart F—General Hospital and Personal Use Therapeutic Devices	Pump, Infusion	Required Intervention	Y
24	801			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y	Leak	HOSPITAL
25	781			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y		UNKNOWN
26	778	PART 882—NEUROLOGICAL DEVICES	Subpart F—Neurological Therapeutic Devices	Shunt, Central Nervous System And Components	Required Intervention	Y	Other (for use when an appropriate device code cannot be identified)
27	767	PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES	Subpart F—General Hospital and Personal Use Therapeutic Devices	Pump, Infusion, Elastomeric	Required Intervention	Y
28	673			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y	Migration of device or device component
29	630			Permanent Defibrillator Electrodes	Required Intervention	Y	Oversensing	HOSPITAL
30	601	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart B—Diagnostic Devices	Laparoscope, General & Plastic Surgery	Required Intervention	Y
31	546			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y	Occlusion within device
32	531	PART 870—CARDIOVASCULAR DEVICES	Subpart B—Cardiovascular Diagnostic Devices	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Death	Y
33	508	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart B—Diagnostic Devices	Laparoscope, General & Plastic Surgery	Required Intervention	Y		NOT APPLICABLE
34	506	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart F—Therapeutic Devices	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Required Intervention	Y
35	502	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart F—Therapeutic Devices	System, Peritoneal, Automatic Delivery	Required Intervention	Y
36	501	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart B—Diagnostic Devices	Endoscope And/Or Accessories	Required Intervention	Y		NOT APPLICABLE
37	463			Permanent Defibrillator Electrodes	Required Intervention	Y	Inappropriate shock	HOSPITAL
38	460			Permanent Defibrillator Electrodes	Required Intervention	Y	Dislodged or dislocated	HOSPITAL
39	459	PART 870—CARDIOVASCULAR DEVICES	Subpart D—Cardiovascular Prosthetic Devices	System, Balloon, Intra-Aortic And Control	Required Intervention	Y	Balloon rupture
40	456	PART 872—DENTAL DEVICES	Subpart D—Prosthetic Devices	Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer	Disability	Y
41	434			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y	Inaccurate delivery
42	425			Permanent Defibrillator Electrodes	Required Intervention	Y	No code available
43	416			Permanent Defibrillator Electrodes	Life Threatening	Y	No code available
44	412	PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES	Subpart F—General Hospital and Personal Use Therapeutic Devices	Lift, Patient, Non-Ac-Powered	Required Intervention	Y
45	405	PART 888—ORTHOPEDIC DEVICES	Subpart D—Prosthetic Devices	Fastener, Fixation, Nondegradable, Soft Tissue	Required Intervention	Y	Unknown (for use when the device problem is not known)	HOSPITAL
46	389			Excimer Laser System	Required Intervention	Y
47	376	PART 870—CARDIOVASCULAR DEVICES	Subpart D—Cardiovascular Prosthetic Devices	System, Balloon, Intra-Aortic And Control	Required Intervention	Y	Difficult to insert
48	366	PART 878—GENERAL AND PLASTIC SURGERY DEVICES	Subpart E—Surgical Devices	Stapler, Surgical	Hospitilization	Y
49	364			Permanent Defibrillator Electrodes	Required Intervention	Y
50	348			Ventricular (Assisst) Bypass	Required Intervention	Y	Other (for use when an appropriate device code cannot be identified)	HOME
51	334	PART 870—CARDIOVASCULAR DEVICES	Subpart C—Cardiovascular Monitoring Devices	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Death	Y
52	334			Permanent Defibrillator Electrodes	Required Intervention	Y	High capture threshold	HOSPITAL
53	333	PART 890—PHYSICAL MEDICINE DEVICES	Subpart D—Physical Medicine Prosthetic Devices	Wheelchair, Powered	Required Intervention	Y
54	333	PART 878—GENERAL AND PLASTIC SURGERY DEVICES	Subpart E—Surgical Devices	Powered Laser Surgical Instrument	Required Intervention	Y
55	315	PART 890—PHYSICAL MEDICINE DEVICES	Subpart D—Physical Medicine Prosthetic Devices	Wheelchair, Powered	Hospitilization	Y
56	302			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y		HOSPITAL
57	301			Permanent Defibrillator Electrodes	Required Intervention	Y	Low sensing threshold	HOSPITAL
58	300	PART 870—CARDIOVASCULAR DEVICES	Subpart E—Cardiovascular Surgical Devices	Clamp, Vascular	Required Intervention	Y		HOSPITAL
59	297	PART 868—ANESTHESIOLOGY DEVICES	Subpart F—Therapeutic Devices	Ventilator, Continuous, Facility Use	Required Intervention	Y		HOSPITAL
60	288			Permanent Defibrillator Electrodes	Required Intervention	Y	High impedance	HOSPITAL
61	282			Permanent Defibrillator Electrodes	Required Intervention	Y	High impedance
62	273	PART 878—GENERAL AND PLASTIC SURGERY DEVICES	Subpart E—Surgical Devices	Electrosurgical, Cutting & Coagulation & Accessories	Required Intervention	Y		HOSPITAL
63	267	PART 868—ANESTHESIOLOGY DEVICES	Subpart F—Therapeutic Devices	Ventilator, Continuous, Facility Use	Required Intervention	Y
64	251			Inhibitor, Peridural Fibrosis (Adhesion Barrier)	Required Intervention	Y
65	250			Permanent Defibrillator Electrodes	Required Intervention	Y	Failure to capture
66	249	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart B—Diagnostic Devices	Endoscope And/Or Accessories	Required Intervention	Y
67	243			System, Endovascular Graft, Aortic Aneurysm Treatment	Death	Y	No Known Device Problem
68	236			Permanent Defibrillator Electrodes	Required Intervention	Y	Device sensing issue
69	235			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y	No Known Device Problem
70	232	PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES	Subpart B—Clinical Chemistry Test Systems	System, Test, Blood Glucose, Over The Counter	Hospitilization	Y		NOT APPLICABLE
71	231	PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES	Subpart F—General Hospital and Personal Use Therapeutic Devices	Pump, Infusion	Life Threatening	Y
72	228			System, Endovascular Graft, Aortic Aneurysm Treatment	Death	Y	Leak
73	228	PART 878—GENERAL AND PLASTIC SURGERY DEVICES	Subpart E—Surgical Devices	Electrosurgical, Cutting & Coagulation & Accessories	Hospitilization	Y
74	226	PART 878—GENERAL AND PLASTIC SURGERY DEVICES	Subpart E—Surgical Devices	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	Required Intervention	Y	Break	HOSPITAL
75	225			Ventricular (Assisst) Bypass	Death	Y	Other (for use when an appropriate device code cannot be identified)	HOSPITAL
76	225	PART 886—OPHTHALMIC DEVICES	Subpart E—Surgical Devices	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Required Intervention	Y	Unknown (for use when the device problem is not known)
77	222	PART 882—NEUROLOGICAL DEVICES	Subpart F—Neurological Therapeutic Devices	Shunt, Central Nervous System And Components	Required Intervention	Y	Program, failure to
78	222	PART 888—ORTHOPEDIC DEVICES	Subpart D—Prosthetic Devices	Fastener, Fixation, Biodegradable, Soft Tissue	Required Intervention	Y
79	217	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart F—Therapeutic Devices	System, Peritoneal, Automatic Delivery	Death	Y
80	217	PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES	Subpart F—Obstetrical and Gynecological Therapeutic Devices	Device, Occlusion, Tubal, Contraceptive	Required Intervention	Y
81	216	PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES	Subpart B—Clinical Chemistry Test Systems	System, Test, Blood Glucose, Over The Counter	Required Intervention	Y	Unable to obtain readings	OTHER
82	215	PART 888—ORTHOPEDIC DEVICES	Subpart B—Diagnostic Devices	Arthroscope	Required Intervention	Y
83	211	PART 868—ANESTHESIOLOGY DEVICES	Subpart F—Therapeutic Devices	Ventilator, Continuous, Facility Use	Death	Y
84	209	PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES	Subpart F—General Hospital and Personal Use Therapeutic Devices	Pump, Infusion	Death	Y
85	209			System, Endovascular Graft, Aortic Aneurysm Treatment	Required Intervention	Y	Implant, removal of
86	207	PART 882—NEUROLOGICAL DEVICES	Subpart B—Neurological Diagnostic Devices	Device, Monitoring, Intracranial Pressure	Required Intervention	Y
87	199			Permanent Defibrillator Electrodes	Required Intervention	Y	Low impedance	HOSPITAL
88	199	PART 888—ORTHOPEDIC DEVICES	Subpart E—Surgical Devices	Screwdriver	Required Intervention	Y
89	198	PART 886—OPHTHALMIC DEVICES	Subpart E—Surgical Devices	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Required Intervention	Y	Burn of device or device component
90	193	PART 878—GENERAL AND PLASTIC SURGERY DEVICES	Subpart E—Surgical Devices	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	Required Intervention	Y
91	192	PART 876—GASTROENTEROLOGY-UROLOGY DEVICES	Subpart B—Diagnostic Devices	Laparoscope, General & Plastic Surgery	Required Intervention	Y		HOSPITAL
92	188			Permanent Defibrillator Electrodes	Required Intervention	Y	Dislodged or dislocated
93	183			Permanent Defibrillator Electrodes	Required Intervention	Y	Break	HOSPITAL
94	180	PART 864—HEMATOLOGY AND PATHOLOGY DEVICES	Subpart F—Automated and Semi-Automated Hematology Devices	System, Multipurpose For In Vitro Coagulation Studies	Required Intervention	Y
95	177	PART 890—PHYSICAL MEDICINE DEVICES	Subpart D—Physical Medicine Prosthetic Devices	Wheelchair, Mechanical	Required Intervention	Y
96	172			Permanent Defibrillator Electrodes	Required Intervention	Y	No Information
97	171	PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES	Subpart F—General Hospital and Personal Use Therapeutic Devices	Pump, Infusion	Hospitilization	Y
98	168			Permanent Defibrillator Electrodes	Required Intervention	Y	Failure to capture	HOSPITAL
99	166			Instrument, Ultrasonic Surgical	Required Intervention	Y		NOT APPLICABLE
100	158	PART 882—NEUROLOGICAL DEVICES	Subpart E—Neurological Surgical Devices	Neurological Stereotaxic Instrument	Required Intervention	Y