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.Based on the results of the investigation, the root cause of the event was unable to be identified.It is likely that the bending part may have been damaged due to physical stress being applied to it.If handled according to the instructions for use (ifu) below, the user may be able to detect the event.Instruction manual urf-v3/v3r operation manual.Chapter 3 preparation and inspection.Users may be able to reduce/prevent the occurrence of this event by handling it in accordance with the ifu below.Instruction manual urf-v3/v3r operation manual: important information: please read before use_ precautions:do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and or perforations.It could also cause parts of the endoscope to fall off inside the patient.Chapter 4 operation 4.1 warnings and cautions: operation :do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist.Do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.Olympus will continue to monitor field performance for this device.
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