BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PENCIL

    MDR report key: 1011221 · Received January 31, 2008

    Report

    Report Number
    1011221
    Event Type
    Malfunction
    Date Received
    January 31, 2008
    Date of Event
    September 10, 2007
    Report Date
    December 3, 2007
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING HERNIA REPAIR, ESU PENCIL WAS SOUNDING AS THOUGH IT HAD BEEN ACTIVATED. HOWEVER, NO ONE WAS TOUCHING IT OR THE MACHINE. THE LIGHT WAS LIT AT THE CUTTING PORTION OF THE MACHINE, INDICATING IT WAS IN USE. THE MACHINE WAS IMMEDIATELY TURNED OFF AND A NEW HANDPIECE WAS CONNECTED AND APPEARED TO WORK WITHOUT PROBLEM FOR THE REMAINDER OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE PENCIL HANDPIECE, ESU GEI CONMED CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NO OTHER THERAPIES| NO OTHER THERAPIES