(b)(6) follow up emdr.Engineer evaluation: device was visually inspected and the lot j03 was verified.This confirmed that the device was over 16 years old.The reported defects of broken wire and protruding wire were confirmed.The wire had split into two separate lengths with approximately 1/4" of it protruding from the distal tip and the other end falling into the handle and could not be seen.The split occurred on the wire between the 1st and 2nd segment from the main tube arrangement.The cause of the split was determined to be fatigue/wear experienced over the lifetime of the device.The protruding wire at the distal end was determined to have happened after the memory wire broke and was caused by repeated use of the device after the break.Continuation of the device's use caused the wire to repeatedly push against the tip until it finally pushed through.No evidence was found that the manufacturing personnel, processes, material, equipment or machinery, environment, or design contributed to the complaint failure mode.Based on the physical evidence, the most probable root cause of the complaint failure mode was wear.A review of the device history record (dhr) was performed and did not identify any negative trends or issues that would have contributed to this issue.H3 other text : evaluation has been performed.
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