Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 03/27/2019 |
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.Awaiting on device return to manufacturer.
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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 an unintentional dural opening as a result of this event.It was further reported that the procedure was completed successfully with no post operative complications reported.
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Manufacturer Narrative
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Lot number updated to 18348037.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.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 an unintentional dural opening as a result of this event.It was further reported that the procedure was completed successfully with no post operative complications reported.
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Search Alerts/Recalls
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