BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C

    MDR report key: 2221476 · Received August 17, 2011

    Report

    Report Number
    1717344-2011-00705
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 28, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT UNIT HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE GENERATOR EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED. THE ELECTROSURGICAL PENCIL WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT SELF-ACTIVATED WHEN A UNK TYPE OF PENCIL WAS IN USE DURING A PROCEDURE. THERE WAS NO PT INJURY INVOLVED WITH THE OCCURRENCE. THE SITE BIOMEDICAL ENGINEER WAS NOT ABLE TO DUPLICATE THE REPORTED PROBLEM AT THE SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNKNOWN TYPE ELECTROSURGICAL PENCIL - NO LOT #