This is 6 of 6 reports linked to other mfg report number: 3014334038-2023-00071 ,3014334038-2023-00072, 3014334038-2023-00073, 3014334038-2023-00074, 3014334038-2023-00075.A facility reported a codman perforator (id 261221) did not stop automatically.The product was in contact with the patient, however, no patient injury reported and the event did not led to surgical delay.The drill used was electric medtronic midas.The perforator clicked in place in the drill, and the recommended spring tests were being performed between each burr hole.The perpendicular approach was maintained through the drill process.There was a constant downward pressure.
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The disposable perforator (id 261221) was returned for evaluation.Unique device identification (udi): (b)(4).Failure analysis: visual inspection utilizing unaided eye performed.The unit had a worn label and tooling on the outer drill likely from attempting to free it after plunging during surgery.Spring test attempted: unit had a frozen inner / outer drill but was freed with downward pressure on the inner drill.Once freed, the unit passed the spring test and functioned as designed.Functional test performed: unit successfully drilled 5 holes with no issues and functioned as designed.The complaint condition could not be confirmed, unit passed all functional tests.Root cause- the root cause remains undetermined.The product was received for analysis and the investigation could not confirm the complaint condition.The possible root cause per the failure analyst ¿drill allows to be set incorrectly¿ or ¿user misuse.¿.
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