Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 07/02/2019 |
Event Type
Injury
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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 stop and tore the dura.It was also reported that there was a few minutes delay to repair the dura.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.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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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop and tore the dura.It was also reported that there was a few minutes delay to repair the dura.It was further reported that the procedure was completed successfully.
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Search Alerts/Recalls
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