BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB FORCE

    MDR report key: 3890035 · Received December 13, 2013

    Report

    Report Number
    3890035
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    August 19, 2013
    Report Date
    December 13, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FAR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    AT END OF SURGERY, CIRCULATOR NOTICED A NEARLY DIME SIZED RED RAW ARE ABOVE THE MIDLINE OF THE CEAREAN SECTION INCISION. WHEN SURGEON ASKED WHAT CAUSED THE INJURY HE STATED" THAT IS WAS A BURN FROM THE MALFUNCTIONING BOVIE." AT THE START OF THE PROCEDURE THE BOVIE MALFUCTIONED AND WENT INTO AN ERROR MODE. BOVIE UNPLUGGED AND RESTARTED AND IT READ ERROR AGAIN. WHEN SURGEON TRIED TO USE IT, ONCE AGAIN IT DID THE SAME MALFUNCTION. NEW BOVIE OBTAINED FOR SURGERY AND MALFUNCTIONING BOVIE REMOVED FROM ROOM BY BIOMED. DEVICE TESTED BY BIOMED, NO PROBLEMS FOUND, ALL REQUIRED TESTS ARE WITHIN NORMAL OPERATING PARAMETERS, RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655030 VALLEYLAB FORCE UNIT, ELECTROSURGICAL FAR COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR