The device was returned to olympus for evaluation and the customer's allegation was confirmed, the insertion tube bending section cover was leaking.The device evaluation found that there was a perforation of the bending section rubber which was exposing the internal metal structure.In addition, the distal end was found to have a dent.The investigation is ongoing, 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 olympus representative (on behalf of the customer) reported to olympus, the uretero-reno videoscope was leaking at the distal tip.The issue was found during maintenance.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: there was a perforation of the bending section rubber which was exposing the internal metal structure.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during 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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to stress such as pushing the bending section by excessive force while the bending section was fixed, twisting the bending section by excessive force, or the like.Subsequently, the bending tube may have protruded out of the bending section cover (a-rubber).The instructions for use (ifu) (operation manual) states about handling of insertion section and bending section as below: "important information ¿ please read before use ¦warnings and cautions: warning do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable 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." the ifu (operation manual) states about inspection prior to use for bending section as below: "3.3 inspection of the endoscope ¦inspection of the endoscope 11 inspect the bending section for protruding metallic parts.12 inspect the bending section for bends, twist, or other irregularities while the bending section remains straight.13 inspect the bending section for abnormal bending shape, or other irregularities." the ifu (operation manual) states about caution at angulation as below: "4.1 precautions: caution 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." it is further suggested that the user facility review the method of handling for the device according to the ifu.Olympus will continue to monitor field performance for this device.
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