BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 6834310 · Received August 31, 2017

    Report

    Report Number
    MW5071868
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 18, 2017
    Report Date
    August 28, 2017
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, PLASTIC PIECE OF BIPOLAR FENESTRATED INSTRUMENT BROKE OFF INSIDE PATIENT. THE PIECE WAS RETRIEVED BY TEAM IMMEDIATELY. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616769 INTUITIVE SURGICAL INC. FENESTRATED BIPOLAR GCJ INTUITIVE SURGICAL INC. 470205 N111606150110

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR