Model Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
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Event Description
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It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was further reported that the surgery was completed successfully.No further information was provided.
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Event Description
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It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was further reported that the surgery was completed successfully.No further information was provided.
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Manufacturer Narrative
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H6; 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 rev.F provides instructions on how to test the disengagement function of the perforator prior to use.The ifu also warns: use extreme caution when drilling in conditions such as: ¿ bone that may vary in consistency and/or thickness greater than 1 mm ¿ adherent dura ¿ high intracranial pressure ¿ other abnormalities in the area of penetration the perforator may cut or nick the dura or brain.
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Search Alerts/Recalls
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