BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT

    MDR report key: 3250781 · Received May 28, 2013

    Report

    Report Number
    3250781
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    ATTENDING SURGEON ATTEMPTED TO USE THE MONOPOLAR ON THE ROBOTIC CONSOLE AND ASKED IF THE GRAY CORD WAS PLUGGED IN AS IT WASN'T COAGULATING INSIDE THE PT. I LOOKED AT THE BOVIE UNIT AND THE CORD WAS PLUGGED IN AND THE SETTINGS WERE OK. AS THE SURGEON ATTEMPTED TO USE THE MONOPOLAR CORD AGAIN, HE STATED IT WASN'T WORKING AGAIN. AS SOON AS HE SAID THIS, I WALKED OVER TO THE BOVIE MACHINE AND FOUND THE CONNECTION BETWEEN THE PART OF THE CORD THAT PLUGS INTO THE MACHINE AND THE WIRE TO BE SMOKING AND RED. I QUICKLY UNPLUGGED THE CORD AND IT WAS REMOVED OFF THE FIELD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ROBOTIC PROSTATECTOMY W/RIGHT NERVE SPARING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233526 JARIT ELECTROSURGICAL, CUTTING AND COAGULATION GEI INTEGRA LIFESCIENCES CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR