BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME

    MDR report key: 4200939 · Received September 16, 2014

    Report

    Report Number
    8010047-2014-00534
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 28, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION ALSO CONFIRMED THAT THE CUTTING WIRE WAS BROKEN AT THE COATING PORTION AND THE BROKEN SECTION WAS MELTED AND BURNED. APPROXIMATELY COATING WAS MISSING FROM 3MM FROM THE BROKEN POINT. THERE WERE NO OTHER ABNORMALITIES RELATED TO THE BREAKAGE IN THE SUBJECT DEVICE. ALSO AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME 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. 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 OF THE SUBJECT DEVICE BROKE. THE DOCTOR COMPLETED THE PROCEDURE BY USING ANOTHER DEVICE. THERE WAS NO REPORT OF PT INJURY REGARDING THIS EVENT. DURING THE INVESTIGATION, OMSC FOUND THE PLASTIC COATING ON THE CUTTING WIRE WAS PARTIALLY MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573091 SINGLE USE 3-LUMEN SPHINCTEROTOME SPHINCTEROTOME FDR OLYMPUS MEDICAL SYSTEMS CORPORATION KD-V411M-0720 K4501

    Patients

    Seq Age Sex Outcome Treatment
    1