BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED ELECTROSURGICAL ACTIVE INSTRUMENT

    MDR report key: 77948 · Received March 21, 1997

    Report

    Report Number
    1317214-1997-00032
    Event Type
    Malfunction
    Date Received
    March 21, 1997
    Date of Event
    February 18, 1997
    Report Date
    February 21, 1997
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PENCIL WOULD NOT DEACTIVATE. THE BUTTON WAS RELEASED, THE PENCIL WAS LAID ON THE PT. THE PENCIL REMAINED ON AND BURNED THRU DRAPE TO PT. SUPERFICIAL BURN 1 MM X 1/2MM. NO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL ACTIVE INSTRUMENT ELECTROSURGICAL PENCIL GEI CONMED CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA