BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 3002605 · Received February 15, 2013

    Report

    Report Number
    8010047-2013-00018
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 15, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OMSC FOR EVAL. THE EVALUATION CONFIRMED THAT THE CUTTING WIRE WAS MELTED AND BURNED AT THE MIDDLE OF THE CUTTING WIRE BY HIGH TEMP. THE COATING WAS TORN AT THE BROKEN POINT OF THE CUTTING WIRE AND APPROX 5MM LONG COATING WAS MISSING FROM THE BROKEN POINT TO DISTAL END. THERE WERE NO OTHER ABNORMALITIES RELATED TO THE BREAKAGE IN THE SUBJECT DEVICE. 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." THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEM CORP (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) WITH SPHINCTEROTOMY, THE CUTTING WIRE OF THE SUBJECT DEVICE WAS BROKEN WHEN THE USER TRIED TO ACTIVATE OUTPUT OF A SURGICAL UNIT. THE DEVICE WAS RETURNED TO OMSC FOR EVAL. DURING THE EVAL OF THE DEVICE, OMSC FOUND THE PLASTIC COATING ON THE CUTTING WIRE WAS PARTIALLY MISSING. THE FACILITY REPORTEDLY COMPLETED THE PROCEDURE USING ANOTHER SPHINCTEROTOME. THERE WAS NO REPORT OF PT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67707 SINGLE USE 3-LUMEN SPHINCTEROTOME V SPHINCTEROTOME FDR OLYMPUS MEDICAL SYSTEMS CORPORATION KD-V411M-0730 K2Y13

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK