Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 12/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.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.It was also reported that there was an unintentional durotomy and the cerebral parenchyma was penetrated.It was further reported that there was no adverse consequences to the patient.It was also reported that there were 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.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional durotomy and the cerebral parenchyma was penetrated.It was further reported that there was no adverse consequences to the patient.It was also reported that there were no surgical delay and the procedure was completed successfully.
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Search Alerts/Recalls
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