The customer reported to olympus, the duodenovideoscope had air outlet at the distal end.It was unknown when the issue was found.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: distal end had a crack.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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The device was returned to olympus for evaluation and the customer's allegation of an air leak at the distal end was not confirmed.The device evaluation found the reportable malfunction identified in b5, distal end had a crack.The following non-reportable findings were found during evaluation: suction cylinder had no color, forceps channel port had a dent, scope connector cover unit had a scratch, water tightness was lost due to a pinhole on bending section cover, adhesive around light guide lens had a crack, and adhesive around objective lens had a crack.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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