The device was returned and evaluated, and the issue was confirmed.In addition to the bending tube being broken, and metal sticking out of the bending rubber, the additional evaluation findings are as follows: there was water invasion in the grip unit.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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The customer reported to olympus that the uretero-reno videoscope had bending manipulation and insertion tube defects.There was no patient harm associated with the event.The device was returned and evaluated, and the bending tube was broken, and metal was sticking out of the bending rubber.This mdr (medical device report is being submitted to capture the reportable malfunction found during the device evaluation.
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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.Based on the results of the investigation, it is likely that the bending section was damaged by application of physical stress during user handling.It was possible that damaged components of the bending section stuck into the bending section during user handling, leading to damage.However, the definitive root cause was unable to be determined.The event can be prevented by following the instructions for use which state: "ifu: urf-v2/v2r operation manual.Chapter 3 preparation and inspection: 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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