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Initial RiskResidual Risk
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Risk IDHazardsForeseeable Sequence of EventsHazardous SituationsHarms
Severity
PORisk LevelRisk Controls (Mitigation(s))Control VerificationsControl implemented? (Y/N)
Severity
PORisk Level Initial Benefit Risk Assessment (BRA)
(only required for risk that are orange or red)
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R-Technical-1Electrical ShockRepeated use and cleaning can lead to failure of insulation on electrical components.An uninsulated, electrical component is openly exposed, meaning that it can come into contact with user/patient skin and deliver an electrical shock. Patient or user is burned by electrical shock.428Device case is design so electrical components have layer of insulation in between user contacting surfacesRepeated cleaning testing with inspection for insulation damage. IEC 60601 (electrical safety) 3rd party evaluation and testing
N414N/A
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R-Technical-2Rotational Component MalfunctionFailure of rotational components (motor, gears) to respond to signal input from letting go of the button (the button is stuck) and rotation does not stopThe rotation of the needle is not able to be stopped at the end of the procedure and damages the breast upon removal.Upon removal of the needle, the patient experiences pain, tissue damage, and a larger wound 313Failsafe switch incorporated into the device, that turns of all electrical mechanisms as soon as it is activated. The device will be tested numerous times in order to determine the number of times the device can be used before component malfunction. IEC 60601-1 service life testN313N/A
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R-Technical-3Vibrational Component MalfunctionFailure of vibrational components (motor) to respond to signal input from letting go of the button (the button is stuck) and rotation does not stopThe vibration of the needle is not able to be stopped at the end of the procedure and damages the breast upon removal.Upon removal of the needle, the patient experiences pain, tissue damage, and a larger wound313Failsafe switch incorporated into the device, that turns of all electrical mechanisms as soon as it is activated. The device will be tested numerous times in order to determine the number of times the device can be used before component malfunction. IEC 60601-1 service life testN313N/A
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R-Technical-4Linear Component Malfunction
Failure of linear components (motor, gears) to respond to signal input from letting go of the button (the button is stuck) and rotation does not stopThe linear motion of the needle is not able to be stopped at the end of the procedure and damages the breast upon removal.Upon removal of the needle, the patient experiences pain, tissue damage, a larger wound, or additional needle puncture sites326Failsafe switch incorporated into the device, that turns of all electrical mechanisms as soon as it is activated. The device will be tested numerous times in order to determine the number of times the device can be used before component malfunction. IEC 60601-1 service life testN313N/A
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R-Technical-5Improperly secured needlePart of/entire needle can be broken off due to force of passes, dislodged due to excessive movement, and/or improper securement of the needle to the device.The needle breaks off into the patient's breast during the procedure.The retained needle may cause pain, injury, and may require surgery to remove the needle, followed by appropriate care. 339Design the single use cartridge to be luer lock compatible so that the needles can be properly secured to the device during the procedure. A semi-automatic test on the Luer Lock bore connectors will be performed using a zwicki Line testing machine with torsion drive. ISO 80369 Luer-lock compatibility testN313N/A
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R-Technical-6Device is difficult to sterilizeImproper device sterilization and tissue cross contamination causes infection during the device's use on a new patient.During the procedure, the single use cartridge is not airtight. This causes previous patient's tissue to come into contact with the device. Therefore when the device is used on a new patient, there is a chance of this contaminant tissue coming into contact with the new patient's tissue.The patient experiences an immune response and the wound site becomes infected, and the infection may spread to the rest of the patient's body if timely care is not provided.3515Design an airtight single use cartridge that is able to connect the disposable syringe and needle.We will be outsourcing sterilization testing to Charles River Laboratories. ISO/TS 22456:2021 Sterilization testN339The probability of occurrence is occasional (1 in 10,000) and infection is an issue that can be resolved with a round of antibiotics. On the other hand, the risk of the cancer progressing without a proper diagnosis could be fatal, with a 25% increased risk of death for every 60 days of delayed treatment for late-stage breast cancer for women in Uganda..
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R-Operability-1Motion of the needle makes it difficult to control the device The clinician loses their grip on the device/the patient moves unexpectedly causing them to lose control of the device.The loss of device control results in the needle rupturing a major blood vessel and increasing agitation/damage of surrounding tissue.The patient experiences excessive bleeding (hematoma/hemorrhage) that will require further treatment and care.339Incorporate a damping system near the grip of the device to minimize shaking of the device near the clinician's gripA semi-automatic test on the Luer Lock bore connectors on the cartridge will be performed using a zwicki Line testing machine with torsion drive. ISO 80369 Luer-lock compatibility testN326N/A
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R-Operability-2
Difficulty in maintaining grip of the device The needle punctures a region of the patient or the operator that is not the lesion of interest due to losing grip on the device and/or accidental disturbances.The needle sticks the user or the patient in an area that is not the lesion, drawing blood.The patient or user is injured, and there is a risk of contamination if the needle enters different people. There may be blood loss and stitches may even be required.2510Develop a rubber ergonomic grip to help clinicians hold the device securely. A randomized clinical survey with a high sample size will investigate the amount of control offered by this grip. ISO 6385:2016 Ergonomics testY212N/A
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R-Operability-3Device is difficult to aim during insertionThe clinician aims the device perpendicularly to the breast, causing the needle to puncture the lungs. The needle goes too far into the breast and enters the lungs.The patient's lung collapses. 515Implement a level angle gauge into the device to help more clearly indicate the angle of insertion to the clinician. Test different angles and determine if the level angle gauge responds, in accordance with ISO/TR 230-11:2018 to test the geometric accuracyN515N/A
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R-Patient-1Agitational motion could loosen cancer cells from the tumor microenvironmentDuring the procedure, the excess localized agitation of the needle in the tumour causes cancerous cells to break of from the tumour and enter the bloodstream.The loosened cancer cells from the tumor microenvironment are able to spread into neighboring tissue and blood vessels, increasing the likelihood of metastasis.Increased spread of tumour cells can cause metastasis of the cancer, thereby causing patient symptoms to severely worsen. 515 Mandatory training showing the controls and handling of the device is required prior to purchasing and using device to ensure minimal harm to the patient.Determine whether the use of the device increases metastasis in animal models significantly.N515N/A
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R-Patient-2Agitational motion increases agitation to more tissue than just the lesionThe agitational motion of the needle increases agitation to the breast tissueAs the needle is moving in the breast, more tissue is being damagedThe patient experiences inflammation, pain, bruising2510 Mandatory training showing the controls and handling of the device is required prior to purchasing and using device to ensure minimal harm to the patient.Determine whether the use of the device causes inflammation, pain, and bruising in animal models significantly.N248The probability of occurrence is remote (1 in 100,000) and trauma/bruising is an issue that can be resolved with painkillers. On the other hand, the risk of the cancer progressing without a proper diagnosis could be fatal, with a 25% increased risk of death for every 60 days of delayed treatment for late-stage breast cancer for women in Uganda.
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