STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZYPHR DISP CRAN PERF LRG 14/11; DRILLS, BURRS, TREPHINES & ACCESSORIES
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Model Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problems
Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2023 |
Event Type
Injury
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Event Description
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It was reported that during a procedure for right sylvian bifurcation aneurysm, the perforator bit did not stop spinning at the desired time.It was also reported that there was a delay as a result of this event.It was further reported that there was no medical intervention, no other details at this time.
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Manufacturer Narrative
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H6: 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 procedure for right sylvian bifurcation aneurysm, the perforator bit did not stop spinning at the desired time, this caused a dural tear and the surgeon had to contain a hemorrhage related to that during throughout the procedure.It was also reported that there was a delay as a result of this event.It was further reported that the patient is doing well and the procedure was completed successfully.
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Search Alerts/Recalls
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