BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 2768917 · Received September 25, 2012

    Report

    Report Number
    8010047-2012-00317
    Event Type
    Other
    Date Received
    September 25, 2012
    Date of Event
    August 17, 2012
    Report Date
    August 27, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT BUT OMSC COULD NOT OBTAIN THE CAUSE OF BLEEDING, AND THE INFO WHICH INDICATE RELATIONSHIP BETWEEN THE BLEEDING AND THE DEVICE. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OMSC FOR EVAL. THE EVAL CONFIRMED THAT THE MIDDLE OF THE CUTTING WIRE WAS BROKEN, AND THE BROKEN PART WAS MELTED AND BURNED BY HIGH TEMPERATURE. THE 10MM LENGTH OF THE COATING ON THE CUTTING WIRE WAS MISSING. THERE WAS NO ABNORMALITIES RELATED TO THE PHENOMENON IN THE MANUFACTURING RECORD OF THE SUBJECT DEVICE. OMSC CONCLUDED THAT THE CAUSE OF THE BREAKAGE WAS LIKELY DUE TO HIGH TEMPERATURE CAUSED BY ARC DISCHARGE. THE ARC DISCHARGE WAS LIKELY CAUSED BY SHORT CONTACT LENGTH BETWEEN THE CUTTING WIRE AND THE PAPILLA. 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 TOO STRONG." OMSC CONCLUDED THAT THE BREAKAGE WAS LIKELY DUE TO HIGH TEMPERATURE CAUSED BY ARC DISCHARGE. BLEEDING WAS LIKELY DUE TO THE PT CONDITION BECAUSE BLEEDING ACCOMPANYING EST ARE REPORTED AS HAPPENING ACCIDENTALLY IN CLINICAL ARTICLES. THIS IS ONE OF TWO REPORTS. (B)(4).

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPHINCTEROTOMY, THE CUTTING WIRE OF THE SUBJECT DEVICE WAS BROKEN. THE USER REPORTEDLY TRIED TO CONTINUED THE PROCEDURE WITH DIFFERENT BUT SAME MODEL DEVICE; KD-V411M-0725, HOWEVER, BLEEDING OF THE TARGET SITE OCCURRED AFTER THE PROCEDURE RE-STARTED. THE USER REPORTEDLY TRIED TO STOP THE BLEEDING USING UNCERTAIN MEANS WITHOUT SUCCESS. THE PT WAS SAID TO HAVE BEEN TRANSFERRED TO LAPAROSCOPIC CHOLECYSTECTOMY AND THE BLEEDING WAS TREATED.

    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-0725 0ZK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization