A physician reported disengagement failure of a disposable perforator (id 261221) during surgery while making the fifth burr hole at the tent.Dural damage and minor brain contusion were observed, hemostasis was performed.The drill used with the perforator was a ipc (medtronic), based on information received, it is unknown if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.The event did not led to less than 30 minutes surgical delay.No further information was provided by hospital.
|
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 - visual inspection utilizing unaided eye was performed.Unit had a destroyed label and was soiled with organic material.Spring test attempted: unit had difficulty compressing the spring, likely from organic material impacting motion, but the hudson end was moving freely.Unit had difficulty engaging the drilling mechanism while using consistent downward pressure.Unit was cleaned and re-sleeved to remove organic material, then successfully drilled 5 holes with no issues.The complaint could not be verified.Unit was found to meet all acceptance criteria.Therefore, the complaint condition could not be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Possible root cause: ¿user misuse¿.
|