SMITH & NEPHEW, INC. LIGHT SOURCE, 500XL, XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Model Number 72200568 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a shoulder arthroscopy procedure, a light source, suddenly darkened, shut down and restarted itself.Surgery was completed with a delay greater than 30 minutes with the reported faculty device, shutting it down for a while and restarting it, so back and forth.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H10: h3, h6: the reported device was not returned to the designated complaint facility 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.The complaint was not confirmed.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include an open circuit or defective power supply.No containment or corrective actions are recommended at this time.A review of device records shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.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.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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