Catalog Number 261221 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2021 |
Event Type
malfunction
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Event Description
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A facility reported a perforator did not stop.No patient injury, no surgical delay reported.The drill used with the perforator was a pneumatic medtronic midas rex.The perforator clicked in place in the drill and the recommended spring tests were performed between each burr hole.
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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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N/a.
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Manufacturer Narrative
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The disposable 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.Unit was lightly soiled and had a worn "eo" label.The functional testing was performed using the same protocol it underwent at finished goods testing prior to release: the unit was found to perform as intended and fulfilled the 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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Search Alerts/Recalls
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