BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 2820882 · Received October 31, 2012

    Report

    Report Number
    8010047-2012-00384
    Event Type
    Other
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 4, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER REPORTED THAT THE HOSPITALIZATION WAS NOT FOR THE BLEEDING AND SCARRING BUT AS SCHEDULED. THE SUBJECT DEVICE AND THE DUODENOSCOPE REFERENCED IN THIS REPORT WERE RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE COATING OF THE CUTTING WIRE OF THE DEVICE BROKEN OFF AND THE PART OF THE CUTTING WIRE SURFACE MELTED. THERE WERE NO MISSING PARTS AND ABNORMALITIES IN ITS MANUFACTURING RECORD. THE EVALUATION OF THE DUODENOSCOPE CONFIRMED THAT THERE WAS A DISCOLORATION IN THE FORCEPS ELEVATOR LIKELY MADE BY HIGH TEMPERATURE DURING THE SPHINCTEROTOMY AND NO OTHER ABNORMALITY. OMSC CONCLUDED THAT THE PHENOMENON WAS LIKELY CAUSED BECAUSE THE COATING ON THE CUTTING KNIFE CONTACTED AND BROKEN DURING THE PROCEDURE. THE DEVICE INSTRUCTION MANUAL WARNS USERS THAT "SINCE THE CUTTING WIRE IS VERY THIN, IT MAY BREAK OFF IN THE FOLLOWING CASES: THE DISTANCE BETWEEN THE PAPILLA OF VATER AND THE WIRE IS VERY SHORT, THE OUTPUT IS TOO HIGH OR ACTIVATED WHILE THE WIRE TOUCHES METAL PARTS OF THE ENDOSCOPE, OR THE WIRE IS TIGHTENED TO STRONG." OMSC CONCLUDED THAT THE BREAKAGE WAS LIKELY DUE TO HIGH TEMPERATURE CAUSED BY ARC DISCHARGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) WITH SPHINCTEROTOMY USING THE SUBJECT DEVICE, USE NOTICED BURN, BLEEDING AND SCARRING APART FROM THE VATER. THE USER REPORTEDLY FOUND THE COATING OF CUTTING KNIFE OF THE DEVICE WAS TORN AFTER THEY WITHDRAW IT FROM A DUODENOSCOPE. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH AN UNCERTAIN PAPILLOTOMY KNIFE. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE 3-LUMEN SPHINCTEROTOME V SPHINCTEROTOME FDR OLYMPUS MEDICAL SYSTEMS CORPORATION KD-V411M-0720 27K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK