This report is being updated to provide investigation findings.New information is reported in h6 and h10.The device history record (dhr)s for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of 27 units were produced under this lot number with no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.Visual inspection as received condition found the cutting loop melted and broke off on one side, but still attached on the other end.Also, there are charred marks and melted on the insulation tubes due to thermal damage.However, the blue shaft is straight, and its proximal end is intact.Also, the electrode passed the continuity when checked from both ends of wires to proximal end of shaft.Since the cutting loop was damaged, the electrode will not be checked for energy output.The observed failure is a known phenomenon likely resulting from putting the distal end through excessive stress possibly resulting in physical damage.On page 2 of the device instructions for use (ifu) shipped with the device, the user is provided with the following information relevant to this event: "keep the distal tip of any electrode or cutting loop in the field of view at all times." olympus will continue to monitor the field performance of this device.
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