A physician reported that on (b)(6) 2020, the perforator failed to disengage while performing the 3rd burr-hole during a procedure to treat a subarachnoid hemorrhage (sah) on a (b)(6) male patient.There was injury to the dura mater and bleeding due to artery rupture adhered to dura mater and hemostasis and dural suture were performed.After craniotomy, bypass was performed by end-side anastomosis.A surgical delay within 30 minutes was observed.After the surgery, the patient developed aphasia.
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The 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.The "eo" label was damaged upon arrival to investigation site, no other anomalies were observed.Ifu testing was performed with no observed anomalies.Testing included: applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.Placing thumb pressure on the perforator point to ensure a smooth, positive spring action when engagement occurs.Ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.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.In conclusion, the returned unit was found to work as intended, and met all 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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