BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 8662320 · Received June 3, 2019

    Report

    Report Number
    8662320
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 22, 2019
    Report Date
    May 28, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SHEARS WOULD NOT OPEN/WORK. THIS OCCURRED WITH NO PATIENT HARM. MANUFACTURER RESPONSE FOR HARMONIC ACE CURVED SHEARS, HARMONIC ACE CURVED SHEARS DA VINCI (PER SITE REPORTER): INVESTIGATION TO BE CONDUCTED ON DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456540 HARMONIC ACE SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 480275 00886874112731

    Patients

    Seq Age Sex Outcome Treatment
    1