BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1190123 · Received September 24, 2008

    Report

    Report Number
    1717344-2008-00433
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 25, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDWATCH RPTR WAS CONTACTED AND WE WERE INFORMED THAT A 3RD PARTY WILL INVESTIGATE THE CONMED DEVICES. THE CONTACT STATED THAT NO INVESTIGATION WAS BEING REQUESTED AT THIS TIME FOR THE COVIDIEN GENERATOR AND THAT CONMED HAD INFORMED THEM THE VALLEYLAB GENERATOR WAS COMPATIBLE WITH THEIR DEVICE. REQUESTS FOR FURTHER INFO REGARDING THE INCIDENT ITSELF WERE DECLINED BY THE CONTACT STATING THE INFO SPECIFIED ON THE MEDWATCH WAS ALL THEY WISHED TO COMMUNICATE AT THIS TIME. THIS INCLUDED QUESTIONS ON PT GENDER AND WHETHER THERE HAD BEEN ANY PT INJURY. THE CONTACT DID STATE THAT SETTINGS WERE CUT 80 AND COAG 35 WHEN THIS FIRST OCCURRED, AND THEY BELIEVED BUT WERE UNCERTAIN THAT CUT WAS BEING ACTIVATED WHEN THE INCIDENT OCCURRED.

    Description of Event or Problem · 1

    THE MEDWATCH STATED: THE DR WAS CAUTERIZING THE TONSIL DURING A TONSILLECTOMY. WHILE CAUTERIZING, THERE WAS A SPARK EITHER FROM THE ELECTRODE OR FROM THE ESU HAND PIECE. THE SPARK TURNED INTO A FLAME. THE CONMED BLUE GUARD ( A NON-COVIDIEN PRODUCT) ON THE ELECTRODE ACTUALLY BURNT DURING THE PROCEDURE. THE SETTINGS FOR THE ESU WERE COAG 25, CUT 25. FURTHER INFO ON MEDWATCH: VALLEYLAB (GENERATOR) WORKED APPROPRIATELY FOR OTHER PROCEDURES DURING THE COURSE OF THE DAY.

    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 * CONMED ELECTRODE, ULTRACLEAN, CAT# 139105EXT| LOT 0805202