A facility reported the label of a disposable perforator (id 261221) started to peel and flake off in the patient's brain when drilling.The flakes were removed by using an irrigation, and no patient injury was reported.The device was used for aneurysm clipping.The drill used with the perforator was an electric anspach, the perforator clicked when placed in the drill, and the recommended spring tests were being performed between each burr hole.
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The disposable 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 #1 was heavily soiled with organic material, and had visible flaking on the eto label.Unit looked as if it had gotten wet, likely from irrigation during surgery, but the cause is unknown.Unit #2 had very light soiling, but showed no other visible anomalies.It can be confirmed the eto label flaked off, however the cause is unknown and cannot be confirmed without further information provided from during the surgery.The information was requested from the hospital but no additional information could be given.Therefore, the complaint condition could be confirmed while the root cause of the failure remains undermined.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.
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