BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSERT

    MDR report key: 3111492 · Received May 8, 2013

    Report

    Report Number
    MW5030114
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE UTILIZING HARMONIC ACE CURVED SHEARS FOR ROBOT, BOTTOM PIECE OF SCISSORS BROKE OFF OF SHEARS. BROKEN PIECE OBTAINED AND ENTIRE INSTRUMENT REMOVED FROM FIELD. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200055 HARMONIC ACE CURVED SHEARS INSERT ROBOTIC HARMONIC NAY INTUITIVE SURGICAL 400272 M10130116

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR