BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3140818 · Received May 31, 2013

    Report

    Report Number
    3140818
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE DID NOT CLICK, SURGEON HAD ON BLOOD VESSEL AND WAS UNABLE TO COMPRESS BLOOD VESSEL. CHANGED DEVICE AND NO OTHER ISSUES NOTED, THE DEVICE CLICKED AND WAS ABLE TO COMPRESS BLOOD VESSEL.======================MANUFACTURER RESPONSE FOR ACE36E, HARMONIC (PER SITE REPORTER).======================REP WILL PICKUP DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PRIMARY PROCEDURE: LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242339 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER SUSTAINABILITY SOLUTIONS ACE36E 2403480

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR