BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME

    MDR report key: 4862248 · Received June 17, 2015

    Report

    Report Number
    8010047-2015-00540
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 4, 2015
    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 INVESTIGATION CONFIRMED THAT THE CUTTING WIRE WAS BROKEN AT THE COATED PORTION AND THE BROKEN SECTION WAS MELTED AND BURNED. APPROXIMATELY COATING WAS MISSING FOR 4.5MM FROM THE BROKEN POINT. THER WERE NO OTHER ABNORMALITIES RELATED TO THE BREAKAGE IN THE SUBJECT DEVICE. ALSO AS THE CHECKING OF THE MANUFACTURING RECORD OF THE SAME LOT, NOTHING ABNORMAL WAS DETECTED. AS THE RESULTS OF THE INVESTIGATION, OMSC ASSUMES THAT THE DAMAGE OF THE COATING OCCURRED DUE TO CONTACTING WITH THE METAL PART OF 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 SPARK AND A PART OF THE CUTTING WIRE BECAME EXTREMELY HOT, RESULTING IN BREAKAGE. THE COATING BROKE OFF AND CAME OFF FORM THE CUTTING WIRE BECAUSE OF THE USER HANDLING AFTER THE CUTTING WIRE WAS BROKEN. 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 ENDOSCOPIC SPHINCTEROTOMY (EST) THE OUTPUT AND THE CUTTING KNIFE BROKE WHEN APPLYING CURRENT. THE DOCTOR COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. DURING THE INVESTIGATION ON JUNE 4, OMSC FOUND THE PLASTIC COATING ON THE CUTTING WIRE WAS PARTIALLY MISSING. THERE WAS NO PATIENT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392732 SINGLE USE 3-LUMEN SPHINCTEROTOME SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORPORATION KD-V411M-0725 K5216

    Patients

    Seq Age Sex Outcome Treatment
    1