Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 02/27/2019 |
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.
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Event Description
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It was reported that during a cranial procedure, two perforator bits did not stop.This record addresses one of the perforator bits involved.It was also reported that there was an unintentional durotomy during a bur hole and the brain was slightly damaged as a result of this event.It was also reported that management of hemostasis was required.It was further reported that the procedure was completed successfully.
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Manufacturer Narrative
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The perforator product reported involved with this event was returned for evaluation and the disengagement mechanism within the perforator was tested and functioned as intended.The reported failure of failure to disengage could not be confirmed.
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Event Description
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It was reported that during a cranial procedure, two perforator bits did not stop.This record addresses one of the perforator bits involved.It was also reported that there was an unintentional durotomy during a bur hole and the brain was slightly damaged as a result of this event.It was also reported that management of hemostasis was required.It was further reported that the procedure was completed successfully.
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Search Alerts/Recalls
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