BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1900060 · Received November 9, 2010

    Report

    Report Number
    1717344-2010-00776
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DOCTOR WAS SHOCKED. HIS HAND RECEIVED A FIRST DEGREE BURN AND SOMETHING LIKE ESCHAR WAS IMBEDDED IN HIS RING FINGER. THE SHOCK SIGNIFICANTLY AFFECTED THE DOCTOR AND ANOTHER DOCTOR HAD TO COMPLETE THE PROCEDURE. THE DOCTOR LEFT FOR POSSIBLE TREATMENT BUT WAS LATER REPORTED AS FINE. THE ELECTROSURGICAL PENCIL AND PT RETURN ELECTRODE (PAD) ARE CONMED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other ELECTROSURGICAL PENCIL| CATALOG AND LOT #S UNK| PATIENT RETURN ELECTRODE - CONMED MFR