BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1870150 · Received October 12, 2010

    Report

    Report Number
    1717344-2010-00696
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 17, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A COUPLE HOURS INTO MASTECTOMY PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST. PATIENT RECOVERED AND WAS MOVED TO INTENSIVE CARE AND SUBSEQUENTLY DISCHARGED TO HOME. THE PATIENT SUFFERED FROM TAKOTSUBO CARDIOMYOPATHY.

    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 47 YR Life Threatening| O ES ELECTRODE, (B)(4)| ES PENCIL, (B)(4)| PATIENT RETURN ELECTRODE, (B)(4), LOT #S UNKNOWN