It was reported that, during surgery, a ss meta semiextended drill guide probe displayed error message indicating failure while in use.After disconnect and connect to the another probe sensor port on the interface, it was the same.Surgery was finished with a back-up device, with less than 5 minutes of surgical delay.Patient was not injured as consequence of this problem.
|
The device was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from misuse, a broken wire in a cable, a damaged connector, software not programmed correctly, software not updated, connection or mechanical issues, or an open circuit on the data line are likely probable causes of the reported event.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Additional information: d3.
|