BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB FORCE FX

    MDR report key: 1848581 · Received September 24, 2010

    Report

    Report Number
    MW5017589
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 24, 2010
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAP CHOLE PROCEDURE, PHYSICIAN WAS USING FOOT PEDAL CAUTERY - STATED IT WAS NOT WORKING PROPERLY. ALL EQUIPMENT CHECKED AND THERE WAS NO REASON WHY EQUIPMENT WOULD NOT WORK. THEN A SPARK AND FLAME JUMPED UP AT THE JOINT OF CORD. DR EXTINGUISHED THE FLAME - NO INJURY TO PT - CORD WAS BURNED COMPLETELY THROUGH. DATES OF USE: (B)(6)2010. DIAGNOSIS OR REASON FOR USE: SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB FORCE FX MONOPOLAR CORD GEI OLSEN MEDICAL 90056 014589

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other