BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED PENCIL

    MDR report key: 725937 · Received June 6, 2006

    Report

    Report Number
    1720159-2006-00027
    Event Type
    Malfunction
    Date Received
    June 6, 2006
    Date of Event
    May 8, 2006
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PENCIL FAILED A FUNCTIONAL TEST WITH A TEST ESU. THE PENCIL WAS ACTIVE AT THE MOMENT OF CONNECTION INTO THE GENERATOR. THIS WAS DUE TO A RESIDUE ON THE SURFACE OF THE PWB BOARD. ONCE THE RESIDUE WAS REMOVED, THE SHORT BETWEEN WIRES WAS GONE. NO OBVIOUS SOLDER SHORT WAS SEEN ON EITHER SIDE OF THE INTERNAL BOARD.

    Description of Event or Problem · 1

    THE PENCIL REMAINED ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED PENCIL ELECTROSURGICAL PENCIL GEI CONMED ELECTROSURGERY * 0512091

    Patients

    Seq Age Sex Outcome Treatment
    1 *