The device was returned and evaluated.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: the universal cord had coating peeling; the adhesive around the objective lens had discoloration; the adhesive around the light guide lens had a crack; the connecting tube had a wrinkle; the suction cylinder had no color; and the air-water cylinder had no color.Additionally, the following parts were found to have scratches: grip, switch box, right, left, up, and down knob.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 evis exera ii duodenovideoscope was leaking.It is unknown when the issue was found and there is no known procedure information.The device was returned for evaluation.During the device evaluation, the distal end had a crack was found.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the 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.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, the cracked distal end may have resulted from physical or chemical stress.However, the specific cause of the damage could not be determined.Olympus will continue to monitor field performance for this device.
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