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 09/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.Device received but awaiting evaluation results.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was no adverse consequences as a result of this event.It was further reported that there was no surgical delay and the procedure was completed successfully.The malfunction occurred on three separate devices in the same procedure.This record address one of these instances.
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Manufacturer Narrative
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H6: the quality investigation is complete.H3 other text : device not available for return.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was no adverse consequences as a result of this event.It was further reported that there was no surgical delay and the procedure was completed successfully.The malfunction occurred on three separate devices in the same procedure.This record address one of these instances.
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Search Alerts/Recalls
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