BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKED GUIDEWIRE

    MDR report key: 1007032 · Received March 3, 2008

    Report

    Report Number
    MW5005766
    Event Type
    Malfunction
    Date Received
    March 3, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 3, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTICED AFTER COMPLETING A STANDARD WIRE GUIDED ESOPHAGEAL DILATATION THAT THE GUIDEWIRE SPRING TIP HAD SEPARATED FROM THE WIRE ON TWO SEPARATE OCCASIONS - 2008 - WITH TWO SEPARATE GUIDEWIRES. FORTUNATELY, THESE SEPARATIONS HAPPENED JUST AFTER THE WIRES WERE REMOVED FROM THE PTS. THIS SAME TYPE OF EVENT OCCURRED AT OUR AGENCY AND WAS REPORTED TO MEDWATCH ON 10/25/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARKED GUIDEWIRE DQX CONMED CORPORATION 000150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR AMERICAN DILATOR