BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 283635 · Received June 26, 2000

    Report

    Report Number
    1720159-2000-00052
    Event Type
    Malfunction
    Date Received
    June 26, 2000
    Date of Event
    January 27, 1999
    Report Date
    May 30, 2000
    Manufacturer
    CONMED/ASPEN LABS
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    BY WAY OF A LAWSUIT, CONMED/ASPEN LABS WAS INFORMED THAT WHILE THE PT WAS UNDERGOING A CESAREAN SECTION PROCEDURE, AN ELECTROSURGICAL PENCIL WAS LEFT TO LIE ON THE PT'S LEFT THIGH. WITHOUT WARNING FROM THE ELECTROSURGICAL GENERATOR, THE ELECTROSURGICAL PENCIL CUT A LARGE GASH IN THE PT'S THIGH WITHOUT MANUAL ACTIVATION. THE WOUND BECAME INFECTED. THE PENCIL MODEL NUMBER AND LOT NUMBER ARE NOT KNOWN IN THE LAWSUIT MENTIONED. THE ONLY RECORDED ORDER FOR CONMED PENCILS IN CUSTOMER SVC RECORDS WAS AFTER THIS EVENT ON 3/99 FOR CATALOG NUMBER 130309 CONMED PENCILS. THEREFORE, WITHOUT ANY OTHER INFO AT THIS TIME AND UNTIL CO LEARNS OTHERWISE, THE PENCIL WILL BE REPORTED AS A 130309 CONMED PENCIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL PENCIL GEI CONMED/ASPEN LABS CONMED PENCIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ELECTROSURGICAL GENERATOR MFG BY VALLEYLAB MODEL| FORCE FX.