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 manufacturing site and evaluated.It was reported that during a shoulder scope, the hd arthroscope/sinuscope 4.0mm x 30 deg x 167mm (mitek lock) was scratched.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: minor scratches on the unit, outer tube damaged - bent/dented outer tube, distal tip damaged - shaver damage to distal tip, holes in distal tip fiber - fibers sunken in, illumination, optical system, optical components - broken lenses in optical system.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.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 sales rep that during a shoulder scope surgery on (b)(6) 2021, it was observed that the hd arthroscope/sinuscope 4.0mm x 30 deg x 167mm (mitek lock) endoscope device was scratched.During in-house engineering evaluation, it was determined that the device had broken lenses in its optical system.Another like device was used to complete the procedure with a delay of one minute.There were no adverse patient consequences reported.No additional information was provided.
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