BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS ENDOWRIST

    MDR report key: 4212515 · Received October 27, 2014

    Report

    Report Number
    4212515
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    DURING A ROBOTIC LEFT LOWER LOBECTOMY, A MONOPOLAR CURVED SCISSOR ENDOWRIST WAS PLACED THROUGH A TROCAR AND WHEN THE TIP WAS VIEWED IN THE CHEST CAVITY, THERE APPEARED TO BE A 1CM SECTION MISSING OF THE ORANGE/BLACK SECTION AND THE TIP WAS AT A 90 DEGREE ANGLE. AFTER THE LOBE WAS REMOVED, THE PIECE WAS LOCATED BY THE SURGEON AND APPEARED AS A COMPLETE MATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684453 MONOPOLAR CURVED SCISSORS ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420179 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * UNKNOWN TO THIS REPORTER