BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS

    MDR report key: 3193618 · Received June 21, 2013

    Report

    Report Number
    MW5030687
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 21, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A ROBOTICS SURGERY CASE THE SURGEON NOTICED A BURN HOLE ON THE MONOPOLAR TIP COVER. THE INSTRUMENT WAS REMOVED AND THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282552 INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS HOT SHEARS GEI INTUITIVE SURGICAL, INC 420179 M11130610710
    282553 INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS HOT SHEARS GEI INTUITIVE SURGICAL, INC 400180 M11130610710

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR