BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAND-TROL

    MDR report key: 294094 · Received September 1, 2000

    Report

    Report Number
    294094
    Event Type
    Other
    Date Received
    September 1, 2000
    Date of Event
    August 1, 2000
    Report Date
    August 7, 2000
    Manufacturer
    CONMED ASPEN SURGICAL SYSTEM
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CONMED "HAND-TROL" HAND CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE INADVERTENTLY ACTIVATED BY USER CAUSING 3 MINOR CAUTERY BURNS ON PT'S ABDOMEN. FIRST NOTED BY RN WHEN REMOVING SURGICAL DRAPES AT THE END OF SURGERY FOR TOTAL ABDOMINAL HYSTERECTOMY/BILATERAL SALPINGO-OOPHORECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAND-TROL HAND CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE GEI CONMED ASPEN SURGICAL SYSTEM * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other MODEL EXCALIBER CAUTERY MACHINE.