BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE

    MDR report key: 2602390 · Received September 30, 2009

    Report

    Report Number
    2602390
    Event Type
    Malfunction
    Date Received
    September 30, 2009
    Report Date
    August 24, 2009
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    JOK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO REMOVE INSTRUMENT I WAS UNABLE TO WITHDRAW IT COMPLETELY THROUGH THE PORT CANNULA. THE PORT CANNULA INSTRUMENT WERE VISUALIZED USING THE CAMERA AND IT WAS NOTED THAT THE SCISSOR END HAD SEPARATED FROM THE SHAFT OF INSTRUMENT. IT APPEARED TO HAVE GOTTEN CAUGHT ON THE CANNULA (PORT) AND BROKEN AT THAT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTUITIVE METZ SCISSOR INSTRUMENT JOK INTUITIVE SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other