A physician reported disengagement failure of a perforator ((b)(4)) during surgery, causing dural damage and a minor brain contusion.Dural reconstruction was performed, and the event led to surgical delay of less than 30 minutes.The procedure was completed with a replacement product available.The manufacturer of the drill is a primado/nakanishi.According to information provided, it is unknown if the perforator clicked in place with the drill, or if the recommended spring tests were performed between each burr hole.It is also unknown if the angle approach was perpendicular as the ifu (instructions for use) states, and if there was constant downward pressure.
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Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Perforator (id 261221) has been 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 - a visual inspection showed that the unit was lightly soiled with organic material, but no other anomalies were observed.Unit passed spring test and functioned as designed.Functional test performed and the unit successfully drilled 5 holes with no issues and functioned as designed.Root cause - product was received for analysis and the analyst could not confirm the complaint condition.Possible root cause per the failure analyst ¿user misuse or drill allows to be set incorrectly".
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