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 12/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Awaiting device evaluation.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 disengage.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 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 ifu #5100-060-700 revision f provides instructions on how to test the disengagement function of the perforator prior to use.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 disengage.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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