BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS

    MDR report key: 3171948 · Received June 3, 2013

    Report

    Report Number
    3171948
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 3, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    DURING THE ROBOTIC CASE, THE HARMONIC INSERT JAW TIP BROKE OFF. THE PIECE WAS RETRIEVED WITH NO APPARENT INJURY TO THE PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245290 HARMONIC ACE CURVED SHEARS SYSTEM, SURGICAL, COMPUTER CONTROLLED NAY INTUITIVE SURGICAL, INC. * M10130311

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR