Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device is available for return.A follow up report will be filed once 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 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.
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Manufacturer Narrative
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The reported event, for perforator bit failure to disengage, was not confirmed as the perforator bit was not returned for evaluation.Without the perforator bit, the root cause cannot be determined.Device not returned for evaluation.
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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.
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Search Alerts/Recalls
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