BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD FOOTSWITCH

    MDR report key: 2082691 · Received April 28, 2011

    Report

    Report Number
    1717344-2011-00326
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. EVAL OF THE INCIDENT FOOTSWITCH CONFIRMED THE REPORT. TESTING FOUND THE CUT SWITCH TO LATCH IN THE ON POSITION. THIS IS AN ISOLATED FAILURE. VISUAL INSPECTION OF THE FOOTSWITCH FOUND THE BASEPLATE BENT AND THE RUBBER FEET MISSING. THE CONDITION OF THE FOOTSWITCH IS A COMBINATION OF USE OVER A LONG PERIOD OF TIME AND ROUGH HANDLING BY THE USER. THE SUPPLIER DETERMINED THE FOOTSWITCH WAS MANUFACTURED PRIOR TO 1993 AND THE DEVICE HISTORY RECORDS ARE NO LONGER AVAILABLE FOR REVIEW. DUE TO THE AGE AND CONDITION OF THE FOOTSWITCH, IT IS CONSIDERED TO HAVE EXCEEDED LIFE EXPECTANCY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC GALLBLADDER SURGERY, THE FOOT PEDAL IN USE BECAME STUCK IN COAG MODE. THE SCISSORS THAT WERE BEING USED BY THE SURGEON WERE INADVERTENTLY ACTIVATED, CAUSING A BURN TO THE PT. THE PT REC'D AN INTERNAL BURN ON THEIR DIAPHRAGM. THE BURN WAS STITCHED CLOSED USING AN ENDO STITCH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD FOOTSWITCH ELECTROSURGICAL FOOTSWITCH GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR