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Model Number 72202087S |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during a knee arthroscopy, the arthroscope was not working.The procedure was completed with a delay greater than 30 minutes using a smith and nephew back-up device.No further complications were reported.
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Event Description
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It was reported that, during a knee arthroscopy, the arthroscope had picture issues.The procedure was completed with a delay greater than 30 minutes using a smith and nephew back-up device.No further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference (b)(4).H3, h6: the reported device was returned to the designated complaint unit for independent evaluation.A visual inspection of returned device found distal tip damage, sidearm damage, negative lens damage, dented and bent needle.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A complaint history review of the part found similar events.There was a relationship found between the device and the reported event.The complaint was confirmed, and the root cause was associated with an unintended use of the device.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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