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Model Number 242018 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the lens of the scope is 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, distal tip damaged, optical system, optical components, broken lenses in optical system, minor scratches on the unit.The 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 customer that during a knee arthroscopy procedure on (b)(6) 2021, it was observed that the hd epscp,4.0,30,167,mitek device had cracked.Lens.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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