BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED CORPORATION

    MDR report key: 302314 · Received October 24, 2000

    Report

    Report Number
    1720159-2000-00081
    Event Type
    Malfunction
    Date Received
    October 24, 2000
    Date of Event
    September 1, 2000
    Report Date
    September 26, 2000
    Manufacturer
    CONMED/ASPEN LABS
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MACHINE HAS AN OUTPUT MALFUNCTION. NORMALLY CUT 300W BUT MEASURES 430W, POWER SUPPLY OUTPUT VOLTAGE HIGH.

    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