Model Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 07/22/2021 |
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 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 bit did not stop spinning at the desired time.It was also reported that there was an unintentional dural opening causing a lesion of the cerebral cortex producing a contusion requiring homeostasis and coagulations a result of this event.It was further reported a delay of unknown duration occurred as a result of this event.It was also reported that the procedure was completed successfully.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional dural opening causing a lesion of the cerebral cortex producing a contusion requiring homeostasis and coagulations a result of this event.It was further reported a delay of unknown duration occurred as a result of this event.It was also reported that the procedure was completed successfully.
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Manufacturer Narrative
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H6: the quality investigation is complete.
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Search Alerts/Recalls
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