BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTUITIVE SURGICAL SYSTEMS

    MDR report key: 3952688 · Received July 17, 2014

    Report

    Report Number
    MW5037358
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    July 17, 2014
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER 10 MINUTES OF USE, THE SINGLE SITE FENESTRATED BIPOLAR FORCEP JOINT BROKE AND STOPPED ARTICULATING. INSTRUMENT WAS REMOVED FROM THE TROCAR AND IT WAS REPLACED WITH A CROCODILE GRASPER. NO APPARENT INJURY TO THE PT. REASON FOR USE: BILATERAL OVARIAN CYSTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420117 INTUITIVE SURGICAL SYSTEMS FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL 428093

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention