Model Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Event Description
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It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was further reported that there were no adverse consequence as a result of the reported event.It was also reported that a delay of a few minutes occurred as a result of this event.It was also reported that the surgery was completed successfully.
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
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Manufacturer Narrative
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H6: the quality investigation is complete.
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Event Description
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It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was further reported that there were no adverse consequence as a result of the reported event.It was also reported that a delay of a few minutes occurred as a result of this event.It was also reported that the surgery was completed successfully.
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Search Alerts/Recalls
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