The device was returned to olympus for evaluation, and the customer's allegation was confirmed.Additionally, the device evaluation found the adhesive on the protective coating of the bending portion of the device was cracked, the label on the light guide connector was peeled, the universal cord was damaged and the coating was peeling, the up/down plate was discolored, the protector of the video cable had a cut, the connecting tube was wrinkled, the video connector case was cracked, and scratches were on the video connector, the light guide connector, the universal cord, the up/down angulation lock lever, the up/down plate, the grip, the switch box, the scope cover, the control unit, the video cable, the connecting tube, and the video connector case.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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The customer reported to olympus, the visera cysto-nephro videoscope had lost the water tightness due to a cut on the switch 1.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found the forceps channel port was damaged.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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