Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problems
Abrasion (1689); Brain Injury (2219)
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Event Date 04/03/2018 |
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 continued to drill beyond expected time and perforated the dura.It was also reported that the bone flap was located between the cortex and brain tissue.It was further reported that the patient will experience some form of brain damage, yet to be assessed.It was also reported that the surgery was delayed for less than 30 minutes.
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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 expected time and perforated the dura.It was also reported that the bone flap was located between the cortex and brain tissue.It was further reported that the patient will experience some form of brain damage, yet to be assessed.It was also reported that the surgery was delayed for less than 30 minutes.
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Search Alerts/Recalls
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