Model Number 72202959S |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).
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Event Description
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It was reported that during a knee arthroscopy, the scope lens were found to be scratched.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.Results of investigation have concluded that this unit had a cracked distal lens which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Internal complaint reference (b)(4).The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found distal tip and fiber damage and a cracked and scratched distal lens.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an repeat event.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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