BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME

    MDR report key: 4200941 · Received September 16, 2014

    Report

    Report Number
    8010047-2014-00537
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 22, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE CUTTING WIRE WAS BROKEN AT THE COATED PORTION AND THE BROKEN SECTIONS WERE MELTED AND BURNED. IN ADDITION, CUTTING WIRE WAS MISSING FOR APPROXIMATELY 10 MM FROM THE BROKEN POINT NEAR THE DISTAL TIP AND THE PLASTIC COATING ALSO MISSING FOR APPROXIMATELY 5 MM. ALSO AS THE LOT, NOTHING ABNORMAL DETECTED. AS THE RESULTS OF THE INVESTIGATION, OMSC ASSUMES THAT THE DAMAGE OF THE COATING OCCURRED DUE TO CONTACTING WITH THE METAL PART OF THE FORCEPS ELEVATOR OF THE ENDOSCOPE. 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 A SPARK AND THE PART OF THE CUTTING WIRE BECAME EXTREMELY HOT, RESULTING IN BREAKAGE. THE COATING AND CUTTING WIRE CAME OFF BECAUSE OF THE USER HANDLER AFTER THE CUTTING WIRE WAS BROKE. THE DEVICE INSTRUCTION MANUAL HAS WARNED ABOUT THE POSSIBILITY OF COATING PEELING AND BREAKAGE OF CUTTING WIRE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYS CORP (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) WITH SPHINCTEROTOME, THE CUTTING WIRE BROKE. THE DOCTOR COMPLETED THE PROCEDURE BY USING ANOTHER DEVICE. DURING THE INVESTIGATION, OMSC FOUND THE CUTTING WIRE AND ITS PLASTIC COATING WAS PARTIALLY MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573992 SINGLE USE 3-LUMEN SPHINCTEROTOME SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORPORATION KD-V431M-0720 K4529

    Patients

    Seq Age Sex Outcome Treatment
    1