OES CHOLEDOCHO FIBERSCOPE

Additional Manufacturer Narrative

THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO LOCAL SERVICE DEPARTMENT OF OLYMPUS. LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND CONFIRMED THE REPORTED PHENOMENON AND IT WAS DUE TO DETERIORATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE FOLLOWING INFORMATION, OMSC PRESUMED THAT THE EVENT WAS CAUSED BY PHYSICAL STRESS / CHEMICAL STRESS / STORAGE ENVIRONMENT, ETC.. - ACCORDING TO THE INSPECTION RESULT BY LOCAL SERVICE DEPARTMENT, THE GRIP WAS DIRTY, AND U/D PLATE, ANGULATION CONTROL LEVER AND S-CYLINDER WERE DISCOLORED. - IFU STATES CAUTION REGARDING PHYSICAL STRESS, REPROCESSING METHOD AND STORAGE ENVIRONMENT OF DEVICE. - ACCORDING TO PAST SIMILAR CASES, IT WAS PRESUMED THAT EVENT WAS CAUSED BY PHYSICAL STRESS / CHEMICAL STRESS / STORAGE ENVIRONMENT, ETC..

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

Description of Event or Problem

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE REPROCESSING, IT WAS FOUND THAT THE COATING OF THE INSERTION TUBE HAD BEEN PARTIALLY PEELED OFF. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.