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Model Number 242018 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
Not Applicable (3189)
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Event Date 01/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Device was used for treatment, not diagnosis.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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It was reported by affiliate via phone that during knee arthroscopy, two hd epscp, 4.0, 30, 167, mitek scopes appeared foggy during a knee scope.They cleared the fog after the case and tested them again and found the foggy came back as there is a possible crack in the seal as they can see moisture.The procedure was completed with a same like device.No patient consequences.There was a surgical delay of 2 minutes reported.The devices are available to be returned for evaluation.
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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.The date device returned to manufacturer has been updated to reflect the correct information.Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had black spots was confirmed.The following defects were found with the device upon evaluation : outer tube damaged, distal tip damaged, distal tip has deposits.Image error, on camera image cloudy/blurred.Moisture in system.The device was repaired, tested and found to be working according to specifications.Lack of cleaning and maintenance of the device is the most probable root cause of the deposits on the distal tip and the moisture inside the system.User mishandling of the device would have further caused the damage to the distal tip.This would have caused the scopes to display a poor image.A manufacturing record evaluation was performed for the finished device (serial number: (b)(6)) number, 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.
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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.A manufacturing record evaluation was performed for the finished device [1300791] number, and no non-conformances were identified.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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Search Alerts/Recalls
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