BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1002665 · Received February 26, 2008

    Report

    Report Number
    8010047-2008-00033
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Report Date
    January 28, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE USER'S REPORT OF A BROKEN SPHINCTEROTOME WIRE. THE DAMAGE WAS CONSISTENT WITH THAT CAUSED BY EXCESSIVE CURRENT. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE WIRE OF THE SPHINCTEROTOME BROKE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR, BUT DIFFERENT DEVICE. THE USER FACILITY WAS CONTACTED SEVERAL TIMES BOTH BY PHONE AND IN WRITING TO OBTAIN ADD'L INFO REGARDING THIS REPORT, HOWEVER, NO ADD'L INFO WAS RECEIVED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SPHINCTEROTOME KNS OLYMPUS MEDICAL SYSTEMS CORPORATION KD-V411M-0 79K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK