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Model Number 242018 |
Device Problems
Break (1069); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.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 damaged - shaver damage to distal tip- holes in distal tip fiber , keel loose/raised, fibers sunken in, illumination distal tip fiber damaged, optical system, optical components broken lenses in optical system, and 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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Event Description
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It was reported by the sales rep that during a knee arthroscopy procedure on (b)(6)2021, ti was observed that the hd epscp,4.0,30,167,mitek endoscope device was bent.During in-house engineering evaluation, it was determined that the device had broken lenses in the optical system.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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Search Alerts/Recalls
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