2 of 3 reports (same failure, different patients) other mfg report numbers: 3014334038-2021-00077, 3014334038-2021-00079.A facility reported that the safety mechanism of the perforator didn't work, and it caused damage to the dura mater (bleeding).The procedure was delayed 20 minutes in order to stop the bleeding.The procedure was completed at the time of the event.
|
Complaint sample was not returned for evaluation (discarded); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
|