A facility reported the automatic clutch mechanism of a perforator (id 261221) did not work and the perforator did not stop after penetrating the patient's skull.The surgeon did not use excessive pressure when nearing the point of perforation, therefore no serious injury caused.The manufacturer of the drill used is an electric aesculap.The perforator clicked in place in the drill.According to information provided, it is unknown if a perpendicular approach was maintained through the drilling process, if there was any rocking motion included and if there was constant downward pressure,.
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The perforator (id 261221) 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.The unit was soiled and had a destroyed eo label due to being autoclaved.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.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.Root cause analysis- the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Potential root cause is likely user misuse.
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