Catalog Number 261221 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problems
Contusion (1787); Injury (2348)
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Event Date 11/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A physician reported a perforator failed to disengage.The perforator was used with an electric drill (medtronic); rotation number was 65000.The perforator was used for a patient with moyamoya disease who had a stroke and was taken to the operating room for an external decompression.Reportedly, the disengagement failure occurred during making the third burr hole for decompression.The recommended spring tests were performed between each burr hole.The dura mater was injured, and a brain contusion was observed.Hemostasis and dural reconstruction were performed.The perforator was changed to another one and the procedure was completed.There was a surgical delay time of 30-minutes due to the perforator failing to disengage.There was no information whether born pad and hole gap were made.
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Manufacturer Narrative
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The perforator was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye: organic matter was observed, no additional anomalies.Ifu testing procedure was performed with no observed anomalies.Functional testing was performed and the unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
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Event Description
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N/a.
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Search Alerts/Recalls
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