Visual inspection was performed on the returned device.The reported kinked coil and separation were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported kinked coil; however, the separation appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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