Additional information received: date of event : april 4th 2023.Product id : 261221.Lot number : 6957549.Device was found unacceptable.Nature of the event: "when using the perforator to gain access to the tumor, it did not disengage allowing to recoil as its supposed to when not on bone and continued to drill.This caused a venous bleed and also the patient to have a temporary cranioplasty made by radiopaque bone cement.".Did the event lead to increase surgery time? if yes for how long (less or more than 30 minutes) - answer : 20 mins how did the medical staff finish the procedure? answer : continued as planned after homeostasis where was the exact location of the 1st burr hole on the frontal side of the skull? left frontal 1cm lateral to midline how much bleeding was observed? 500-750ml how was hemostasis achieved? (e.G.Manual pressure, hemostatic agents, cautery, etc.) - pressure, heamostatis, time was administration of blood products necessary? no what is the healing status of the patient? normal is the patient an adult, a child or a baby? adult was the angle of approach perpendicular as the ifu states? yes was the perpendicular approach maintained through the drilling process or was there any rocking motion included? perpendicular was there constant downward pressure? yes what is the manufacturer of the drill used with the perforator? medtronic was the drill electric or pneumatic? electric did the perforator click in place in the drill? yes are the recommended spring tests being performed between each burr hole? yes.
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The perforator was returned for evaluation: 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 performed noted that the unit was soiled with organic material, but no other anomalies were observed.A functional spring test was performed and its noted that the unit had a frozen inner/outer drill likely from the organic material present.Once the unit was cleaned, 5 test holes were drilled and the inner / outer drills were freed, moving as designed.Once freed the unit passed the spring test.After unit was freed a function test was performed and drilled 5 additional holes with no issue and functioned as designed.Therefore, the complaint condition could not be confirmed.Root cause - product was received for analysis and the analyst could not confirm the complaint condition.Root cause remains undetermined.Possible root cause per the failure analyst ¿user misuse or drill allows to be set incorrectly.¿.
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