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 09/03/2021 |
Event Type
malfunction
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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 facility reported a codman perforator did not stop automatically when meeting no resistance.The perforator was used with an electric midas rex drill.The reported device, clicked in the place in the drill and the recommended spring test were performed between each burr hole.No patient injury reported and the event did not led to surgical delay.
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Manufacturer Narrative
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The codman 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 had worn "eo" label but presented no other anomalies.The "ifu" testing procedure was performed with no observed anomalies.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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