BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1163293 · Received September 9, 2008

    Report

    Report Number
    1717344-2008-00411
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 12, 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 INCIDENT GENERATOR HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED. THE SITE BIOMEDICAL ENGINEER WHO ORIGINALLY CALLED, THE OR CHARGE NURSE AND RISK MGMT WERE CONTACTED AND WERE UNABLE OR DECLINED TO PROVIDE FURTHER INFO REGARDING THE INCIDENT INCLUDING WHETHER OR NOT ANY INJURY WAS INVOLVED. THE SITE DID INDICATE THAT COVIDIEN ES PENCILS ARE USED AT THE SITE, BUT NO INFO WAS AVAILABLE ABOUT THE SPECIFIC PENCIL INVOLVED. THE INCIDENT PENCIL WAS THROWN OUT AND IS NOT BEING RETURNED.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT AN ELECTROSURGICAL PENCIL USED WITH THIS GENERATOR CONTINUED TO ACTIVATE WHEN IT WAS SUPPOSED TO BE OFF.

    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 UNK