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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 09/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi: (b)(4).
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Event Description
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It was reported via complaint submission tool that before trials it was noticed that the view through a hd arthroscope/sinuscope 4.0 mm x 30 deg x 167 mm (mitek lock) is not clear.No surgical delay or patient consequences reported.
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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.Investigation summary: the device was received and evaluated at the service center.The reported complaint that the view through a hd arthroscope / sinuscope 4.0mm x 30 deg x 167mm was not clear was confirmed.The optics were found to be damaged and was replaced to address the reported issue.The device was cleaned, repaired, tested and found to be fully functional.The damaged optics is most likely a result of user error or mishandling of the device.The damaged optics has caused the unclear vision through the scope.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.
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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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Search Alerts/Recalls
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