BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3113346 · Received May 6, 2013

    Report

    Report Number
    3113346
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 6, 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

    HARMONIC TIP BROKE OFF, BUT WAS RETRIEVED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197629 HARMONIC ACE SYSTEM, SURGICAL, COMPUTER CONTROLLED NAY INTUITIVE SURGICAL, INC. 400272 M10130119

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR