BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 2753775 · Received September 12, 2012

    Report

    Report Number
    8010047-2012-00301
    Event Type
    Other
    Date Received
    September 12, 2012
    Date of Event
    August 14, 2012
    Report Date
    August 14, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDR
    Adverse Event
    Yes
    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 USER TRIED TO USE THE SUBJECT DEVICE IN SPITE OF NOTICING THE ABNORMAL DIRECTION OF THE CUTTING WIRE. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE MIDDLE OF THE CUTTING WIRE WAS BROKEN, AND THE BROKEN PART WAS MELTED AND BURNED BY HIGH TEMPERATURE. THE COATING ON THE CUTTING WIRE WAS MISSING FOR 6MM IN LENGTH. OMSC COULD NOT DUPLICATE THE ABNORMAL DIRECTION OF THE CUTTING WIRE. THERE WERE NO OTHER ABNORMALITIES FOUND RELATED TO THE BREAKAGE AND THE BLEEDING IN THE SUBJECT DEVICE. OMSC CONCLUDED THAT THE ABNORMAL DIRECTION OF THE CUTTING WIRE WAS LIKELY DUE TO EXTERNAL FORCE AND THE CAUSE OF THE BREAKAGE WAS LIKELY DUE TO HIGH TEMPERATURE CAUSED BY ARC DISCHARGE. THE ARC DISCHARGE WAS LIKELY CAUSED BY USING COAGULATION MODE. THIS REPORT IS BEING SUBMITTED AS A MEDIAL 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, THE CUTTING WIRE OF THE SUBJECT DEVICE WAS OPERATED TOWARD ABNORMAL DIRECTION, HOWEVER, THE USER CONTINUED THE PROCEDURE AND A BLEEDING OF THE TARGET SITE OCCURRED. THE USER REPORTEDLY TRIED TO STOP THE BLEEDING USING THE SUBJECT DEVICE IN COAGULATION MODE, BUT THE CUTTING WIRE OF THE DEVICE BROKE. IT WAS REPORTED THAT THE BLEEDING WAS TREATED BY USING OTHER SPHINCTEROTOME AND UNKNOWN BALLOON. THE PROCEDURE WAS REPORTEDLY COMPLETED USING A DIFFERENT BUT SIMILAR SPHINCTEROTOME. THE FACILITY REPORTED THAT THE PATIENT WAS UNDER RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE 3-LUMEN SPHINCTEROTOME V SPHINCEROTOME FDR OLYMPUS MEDICAL SYSTEMS CORPORATION KD-V411M-0725 26K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK