BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED CORPORATION

    MDR report key: 278026 · Received May 11, 2000

    Report

    Report Number
    1720159-2000-00038
    Event Type
    Malfunction
    Date Received
    May 11, 2000
    Date of Event
    April 1, 2000
    Report Date
    April 13, 2000
    Manufacturer
    CONMED/ASPEN LABS
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MINOR BURN OCCURRED DURING SURGERY WHILE USING THE CONMED/ASPEN ESU. THE EVENT WAS NOT DOCUMENTED PROPERLY SO EXACTLY WHAT HAPPENED IS UNKNOWN. THE HOSP JUST WANTED THE ESU TESTED BY CONMED/ASPEN TO MAKE SURE IT WAS OPERATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED CORPORATION ELECTROSURGICAL UNIT GEI CONMED/ASPEN LABS EXCALIBUR PLUS PC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA