BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC PROBE

    MDR report key: 3140822 · Received May 28, 2013

    Report

    Report Number
    3140822
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE ABC HANDPIECE THE SURGEON NOTICED THE TIP OF THE HANDPIECE WAS MELTING AND THE DECISION WAS MADE TO STOP USING THE DEVICE. NO PATIENT INJURY OCCURRED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EXPLORATORY LAPAROTOMY, LSO, DEBULKING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233271 ABC PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION * 1302063

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NO OTHER THERAPIES