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Model Number 242018 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
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Event Description
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As reported by the employee via phone while quality checking scopes they found serial number (b)(4) had a cloudy lens and (b)(4) has a burn on lens.No case involved.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6: method codes: a manufacturing record evaluation was performed for the finished device [1315895] number, and no non-conformances were identified.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had a mark on the lens was confirmed.The following defects were found during evaluation : outer tube damaged, distal tip distal tip damaged.Image error on camera.Image cloudy/blurred.Particulate visible on camera.The device was diagnosed and repaired using spare parts and was tested and found to be working according to specifications.The damage to the outer tube is most likely a result of user mishandling of the device.Improper maintenance / cleaning of the device is the most likely root cause of the particulates inside the camera.The damage to the distal tip is likely due to contact with a cutting instrument during a surgical procedure.The defective distal tip and the particulates would have caused the device to display a poor image as reported by the customer.A manufacturing record evaluation was performed for the finished device [serial number : (b)(6) ], and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 correction narrative: d9: the date device returned to manufacturer was updated to reflect the correct information.
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Search Alerts/Recalls
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