Model Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/21/2020 |
Event Type
malfunction
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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 continued to run on longer than expected.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery was completed successfully.
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Event Description
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It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery was completed successfully.
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Manufacturer Narrative
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H6; the reported event, for failure to disengage, was not confirmed as the device was not returned for evaluation.Without the device, the root cause cannot be determined.H3 other text : device not available for return.
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Search Alerts/Recalls
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