The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A few strands of wire fractured on the device, causing it to fray and become inoperable.The clinical/ medical evaluation concluded that this case reports the accord cable frayed while inside the patient during use.Per email communication, there was no patient injury, and the procedure was completed with a minimal delay using a backup device.Since no patient harm is alleged, no further clinical assessment is warranted.A review of complaint history did not reveal additional complaints for the listed batch.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 the risk management file revealed this failure mode was previously identified.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 and instructions for use documents revealed this failure mode was previously identified.The potential probable cause of this event is likely overloading.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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