If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received at the supplier and evaluated.It was reported that the device was cracked.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: endoscope shows scratches, distal tip deposits/discoloration, image is slightly blurred and partially dark, outer tube damaged, distal tip distal tip has deposits, image error, on camera, image cloudy/blurred.The device was repaired, and found to be working according to the specifications.The user error 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 procedure on (b)(6) 2020, it was observed that endoscope device was cracked.During in-house engineering evaluation, it was observed that the device had deposits/discoloration on its distal tip and its image was cloudy/blurred.Another like device was used to complete the procedure.There were no adverse patient consequences or surgical delay reported.No additional information was provided.
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