A physician reported disengagement failure of a codman disposable perforator (id 261221) during surgery for subcortical bleeding.When making the fourth or fifth burr hole in the tent, dural damage and a minor brain contusion were observed requiring hemostasis.The procedure was completed and a total of 5 burr holes were drilled.It is unknown if the event led to surgical delay.It is unknown the drill manufacturer, or if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.
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Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 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.Unit was lightly soiled and had a worn eo label.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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