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Model Number 72203967 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2022 |
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 an arthroscopy, the camera head was getting more heated than normal temperature.Surgery was resumed after a delay greater than 30 minutes, using a back-up device instead.No further complications were reported.
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Manufacturer Narrative
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H6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.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 found similar reported events.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.The complaint was not confirmed.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a failed control board.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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