If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that during an unknown procedure the hd arthroscope/sinuscope 4.0mm x 30 deg x 167mm (mitek lock) was cracked.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: outer tube damaged, needle, outer tube bent, outer tube damaged, distal tip, distal tip damaged, high voltage flashover from electrode , illumination, distal tip fiber damaged, optical system, optical components , broken lenses in optical system , distal cover glass/negative damaged , image error, on camera, image cloudy/blurred, minor scratches on the unit.The defective parts were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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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It was reported by the sales rep that during an unknown surgery on (b)(6) 2021, it was observed that the hd arthroscope/sinuscope 4.0mm x 30 deg x 167mm (mitek lock) device was cracked.During in-house engineering evaluation, it was determined that the device had broken lenses in the optical system and cloudy/blurred images.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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