BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE FX-8C GENERATOR (SHANGHAI)

    MDR report key: 3901513 · Received June 20, 2014

    Report

    Report Number
    3006451981-2014-00662
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 13, 2014
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REF #: (B)(4). DATE OF INITIAL REPORT: (B)(6) 2014. THE INCIDENT UNIT HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING DIATHERMY DURING THE PROCEDURE, THE PT'S PACEMAKER STOPPED WORKING. DIATHERMY WAS STOPPED BUT THE PACEMAKER DID NOT RETURN TO NORMAL FUNCTION AND THE PT WAS ASYSTOLIC FOR 20 SECONDS. THE PT WAS SAFELY PLACED THROUGH PSA. THE PACEMAKER WAS INTERROGATED AND FOUND TO BE FULLY FUNCTIONING. DURING THE PROCEDURE, THE FORCEFX GENERATOR WAS SET AT 30 CUT AND 30 COAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363427 FORCE FX-8C GENERATOR (SHANGHAI) ELECTROSURGICAL GENERATOR GEI COVIDIEN LLC (SHANGHAI)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R