BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME

    MDR report key: 3253602 · Received July 17, 2013

    Report

    Report Number
    8010047-2013-00195
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO SUBJECT DEVICES WERE RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE CUTTING WIRES WERE BROKEN AND THE BROKEN SECTIONS WERE MELTED. THE COATINGS TORE. THE OUTER DIAMETER OF THE CUTTING WIRES WAS WITHIN STANDARD. IN ADDITION, THERE WAS NO ABNORMALITY FOUND UPON INVESTIGATION OF THE MFG RECORD OF THE SAME LOT. OMSC ASSUMES THAT THE DAMAGE OF THE COATING OCCURRED DUE TO CONTACTING WITH THE METAL PART OF THE FORCEPS ELEVATOR, AND THE EXPOSED CUTTING WIRE FROM THE DAMAGED COATING CONTACTED OR CAME CLOSE TO THE METAL PART OF THE FORCEPS ELEVATOR WHILE ACTIVATING THE OUTPUT, WHICH CAUSED SPARK AND A PART OF THE CUTTING WIRE BECAME EXTREMELY HOT, RESULTING IN BREAKAGE. THE BLEEDING OCCURRED AS A COMPLICATION OF EST SINCE THERE WERE NO ABNORMALITIES OF THE DEVICES LEADING TO BLEEDING. THE DEVICE INSTRUCTIONS MANUAL HAS WARNED 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 SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) WITH SPHINCTEROTOME, THE CUTTING WIRE BROKE AND BLEEDING OCCURRED FROM THE INCISED PART. THE DOCTOR STOPPED BLEEDING BY APPLYING PRESSURE USING A BALLOON AND REMOVED CALCULI WITH IT. WHILE THE DOCTOR PERFORMED ADD'L INCISION WITH ANOTHER SPHINCTEROTOME OF THE SAME MODEL DUE TO THE LACK OF INCISION LENGTH, THE CUTTING WIRE BROKE AGAIN. EXTRACTION OF THE CALCULI WAS COMPLETED AFTER THE DOCTOR STOPPED BLEEDING USING AN EPBD BALLOON SINCE IT KEPT BLEEDING. THERE WAS NO REPORT OF PT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331372 SINGLE USE 3-LUMEN SPHINCTEROTOME SPHINCTEROTOME FDR OLYMPUS MEDICAL SYSTEMS CORP. KD-V1411M-0720 33K

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR