OES CHOLEDOCHO FIBERSCOPE

Description of Event or Problem

IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FLEX VIDEO SCOPE FORCEPS CHANNEL PORT WAS SHAVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

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. BASED ON THE RESULTS OF THE INVESTIGATION, ROOT CAUSE COULD NOT BE IDENTIFIED ALTHOUGH IT CAN BE PRESUMED THAT IT WAS CAUSED BY THE SHAFT OF CLEANING BRUSH SCRAPING AGAINST FORCEPS/IRRIGATION PLUG PORT. THE EVENTS CAN BE DETECTED/PREVENTED IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE: INSTRUCTIONS OLYMPUS CHF TYPE P60_ PREPARATION AND INSPECTION_ PREPARATION AND INSPECTION OF THE ENDOSCOPE INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION TUBE INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, PEELING, SCRATCHING, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODY, DROPOUT OF PARTS, ANY PROTRUDING OBJECTS OR OTHER IRREGULARITIES. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.