It was reported that during surgery, the host computer screen for the sureshot targeter displayed an "aiming sureshot is damaged, please replace with another one" message.It is unknown when the event happen relative to surgery.A changed in surgical technique was required to complete the procedure.It is unknown if there was a surgical delay due to this issue.No patient injuries were reported.
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The device used in treatment was returned for evaluation.Visual inspection of the returned device shows very little to no signs of damage, wear and tear from use.Functionals inspection of the returned device confirms that when the device is connected to the system, the system displays the error on the screen that the sureshot targeter is damaged and needs to be replaced.A review of the complaint history, for the listed part revealed prior complaints for the listed failure mode but no other complaints with the same serial number as this is a unique serial device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should 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.We consider this investigation closed.
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