BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 230008 · Received July 1, 1999

    Report

    Report Number
    1720159-1999-00047
    Event Type
    Malfunction
    Date Received
    July 1, 1999
    Date of Event
    June 4, 1999
    Report Date
    June 4, 1999
    Manufacturer
    ASPEN LABORATORIES, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OR TECH WAS PRESENT AND REPORTED THAT A 130310 CONMED PENCIL WAS PLUGGED INTO A VALLEY LAB FORCE 4B, WHEN A YELLOW FIRE ABOUT 2 1/2 TO 3 INCHES SHOT OUT OF A DEEP INCISION BETWEEN THE SIDE OF THE WOUND AND SHOT UP THE SURGEON'S GLOVE. THIS HAPPENED REGARDLESS OF THE ESU SETTINGS. THEY TRIED OTHER VALLEY LAB BLADES IN THE CONMED ESP AND THE PROBLEM REPEATED. THEY SWITCHED TO A VALLEY LAB PENCIL AND THE PROBLEM WENT AWAY. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL PENCIL GEI ASPEN LABORATORIES, INC. CONMED PENCIL 9901211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA EVENT.| VALLEY LAB FORCE 4B- NOT A CONTRIBUTOR TO THIS