BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 222804 · Received May 7, 1999

    Report

    Report Number
    222804
    Event Type
    Malfunction
    Date Received
    May 7, 1999
    Date of Event
    January 28, 1999
    Report Date
    April 9, 1999
    Manufacturer
    CONMED
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, WHEN THE SURGEON WAS USING THE 6" BEND-A-BEAM HANDPIECE, THE TIP MELTED. SETTING AN "ESU" WAS AT 150. THERE WAS NO INJURY TO THE PATIENT. ABC MACHINE #172267. GROUNDING PAD #7-384, LOT #9810261.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED BEND-A-BEAM HANDPIECE GEI CONMED * J98388

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other