BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE FX

    MDR report key: 2800435 · Received October 16, 2012

    Report

    Report Number
    1717344-2012-01066
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 21, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT GENERATOR HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE UNIT IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE SURGEON CLAIMED THE UNIT ACTIVATED ON ITS OWN WITHOUT PRESSING THE FOOTPEDAL ATTACHED TO THE DAVINCI ROBOT. THE PT OUTCOME WAS DESCRIBED AS NEGATIVE AND VERY SERIOUS, WITH THE INITIAL REPORT ALLUDING TO BURNS. THE PT WAS REPORTEDLY TAKEN BACK TO SURGERY AND THEN WAS PLACED IN THE SICU. THE GENERATOR WAS CHECKED OUT AND TESTED FINE AT THE SITE. COVIDIEN ADVISED THE SITE THAT A POSSIBLE SOLUTION TO PREVENT THIS TYPE OF EVENT IS TO USE BIPOLAR CORDS THAT HAVE A SOLID-PLUG CONNECTION WHICH DO NOT ALLOW THEM TO BE ERRONEOUSLY CONNECTED TO THE MONOPOLAR PORT. THE SITE CONTACT WAS NOT ABLE TO PROVIDE INFO AS TO WHAT TYPE OF FOOT PEDAL WAS IN USE DURING THE PROCEDURE, THE TYPE OF INSTRUMENT THAT ACTIVATED AND CREATED THE BURN, OR ADD'L PT INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| O| R UNK FOOTPEDAL: SERIAL #UNK| UNK HANDPIECE: LOT UNK