Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 09/21/2018 |
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 discarded by customer.
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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 during a bur hole as a result of this event.It was further reported that the durotomy required medical intervention.It was also reported that 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 during a bur hole as a result of this event.It was further reported that the durotomy required medical intervention.It was also reported that the procedure was completed successfully.
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Search Alerts/Recalls
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