Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 06/21/2019 |
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 device return.
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Event Description
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It was reported that while drilling a hole during a cranial procedure (exeresis right insular temporal lesion), the perforator bit did not stop and went through dura matter.It was also reported that the patient experienced bleeding and bruising.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.A device history record (dhr) review was performed and all manufacturing specifications were met during the time of manufacture of this product.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 while drilling a hole during a cranial procedure (exeresis right insular temporal lesion), the perforator bit did not stop and went through dura matter.It was also reported that the patient experienced bleeding and bruising.It was further reported that the procedure was completed successfully.
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Search Alerts/Recalls
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