The device was returned to olympus for annual inspection, and the evaluation found the reportable malfunction of the distal end had a crack.The following non-reportable findings were found during device evaluation: grip had a scratch, air/water cylinder had no color, suction cylinder had no color, switch box had a scratch, right/left knob had discoloration, upward/downward angulation control knob had discoloration, water tightness was lost because guide pin of electrical connector was shaved, scope connector cover unit had a scratch, scope connector had a scratch, sheet holder unit had corrosion due to water leakage, light guide lens had a chip, adhesive around light guide lens had a crack, connecting tube had a scratch, adhesive around objective lens had a crack, and universal cord had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was visually inspected, and functional testing was performed.The device did not meet the standard specifications and functions.Based on the results of the investigations, the gap between z-block and c-body was confirmed.The probable cause was determined as due to physical stress such as hitting/dropping distal end or chemical stress such as chemical solution used.However, the root cause of the suggested event could not be specified.Olympus will continue to monitor field performance for this device.
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