Model Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 11/04/2021 |
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.Device not available for return.
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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 as a result of this event.It was further reported that the event caused a 20 minute delay.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 as a result of this event.It was further reported that the event caused a 20 minute delay.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.H3 other text : device discarded by customer.
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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 as a result of this event.It was further reported that the event caused a 20 minute delay.It was also reported that the procedure was completed successfully.
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Manufacturer Narrative
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H6; results code; results code changed from; "no device problem found" to "no findings available".
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Search Alerts/Recalls
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