OES CHOLEDOCHO FIBERSCOPE

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. OLYMPUS LOCAL SERVICE ENGINEER REPORT THAT THE BENDING SECTION OF THE DEVICE WAS LEAKAGE. OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED DUE TO THE BENDING MECHANISM OF THE DEVICE WAS BROKEN BY LEAK OF THE DEVICE. THE INSTRUCTION MANUAL OF THE DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE INFORMATION THAT WAS INADVERTENTLY LEFT OUT OF THE INITIAL/SUPPLEMENTAL MEDWATCH REPORT AND TO CORRECT INFORMATION THAT WAS PROVIDED IN THE INITIAL/SUPPLEMENTAL MEDWATCH REPORT. CORRECTED FIELD: E1 (NAME, TELEPHONE), G2 (COUNTRY NAME). THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE DEVICE, THE REPORTED ISSUE (UNABLE TO ANGULATE) WAS CONFIRMED. IN ADDITION, IT WAS FOUND THAT THE BENDING SECTION COVER AND THE INSTRUMENT CHANNEL WAS LEAKING, THERE WERE WATER MARKS AND CRYSTALS IN THE CONTROL SECTION, THE IMAGE HAD MANY WATERMARKS AND BLACK SPOTS, AND THE LIGHT GUIDE TUBE ROD WAS POOR. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT. IT HAS BEEN OVER 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, SINCE WATER LEAKAGE FROM THE CHANNEL AND THE BENDING SECTION COVER HAS BEEN CONFIRMED, IT IS LIKELY THAT INTERNAL WATER SEEPAGE SUPPRESSED THE MOVEMENT OF INTERNAL ORGANS AND CAUSED THE ANGLE TO MOVE APPROPRIATELY. IT IS LIKELY THAT THE IMAGE QUALITY IS DUE TO WATER INTRUSION. AS IT WAS CONFIRMED THAT THERE WAS SOME DAMAGE TO THE CONTROL UNIT, IT IS LIKELY THAT THIS WAS CAUSED BY STRESS SUCH AS BEING HIT OR DROPPED FROM THE OUTSIDE. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE SPARE EQUIPMENT BE SURE TO PREPARE ANOTHER ENDOSCOPE TO AVOID THAT THE EXAMINATION WILL BE INTERRUPTED DUE TO EQUIPMENT FAILURE OR MALFUNCTION. WARNINGS AND CAUTIONS ¿ DO NOT STRIKE, BEND, HIT, PULL, TWIST, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, AND CONTROL SECTION WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, SUCH AS BURNS, BLEEDING, AND/OR PERFORATION. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. CHAPTER 10 TROUBLESHOOTING 10.2 WITHDRAWAL OF THE ENDOSCOPE WITH AN ABNORMALITY IF AN ABNORMALITY OCCURS WHILE THE ENDOSCOPE IS IN USE, TAKE PROPER MEASURES AS DESCRIBED BELOW. AFTER WITHDRAWAL, RETURN THE ENDOSCOPE FOR REPAIR ACCORDING TO SECTION 10.3, ¿RETURNING THE ENDOSCOPE FOR REPAIR¿." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.

Additional Manufacturer Narrative

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE SUBJECT DEVICE, BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. SINCE THE SUBJECT DEVICE WAS NOT RETURNED, THE EXACT CAUSE WAS UNKNOWN. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

Description of Event or Problem

DURING THE PREPARATION FOR AN UNSPECIFIED PROCEDURE USING THE SUBJECT DEVICE, THE ANGULATION OF THE SUBJECT DEVICE WAS LOCKED. THE USER REPLACED THE SUBJECT DEVICE TO ANOTHER UNSPECIFIED SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT INJURY OTHER THAN REPLACING THE DEVICE.