Catalog Number 261221 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 perforator did not stop automatically.The perforator was used with an electric medtronic midas drill.The perforator clicked in place in the drill and the recommended spring tests were performed between each burr hole.No patient injury and no surgical delay was reported.
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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 a worn eo label but showed no other observable 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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Event Description
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N/a.
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Search Alerts/Recalls
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