Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 02/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device is available for return.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 continued to drill beyond the expected time and perforated the dura.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.
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Event Description
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It was reported that during a cranial procedure, the perforator bit continued to drill beyond the expected time and perforated the dura.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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