BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3580389 · Received January 13, 2014

    Report

    Report Number
    3580389
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 13, 2014
    Manufacturer
    ETHICON
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM NEEDED TO OPEN ACE HARMONIC PISTOL GRIP THREE TIMES BEFORE GETTING ONE TO WORK. SENDING BACK DEFECTIVE UNITS TO RISK MANAGEMENT. NO HARM TO PATIENT OCCURRED BUT DID ADD ADDITIONAL SURGICAL TIME. TOTAL NUMBER OF DEVICES SENT TO RM WAS 2. ONE WAS FROM STERILMED AND WAS A REPROCESSED DEVICE FOR SINGLE USE. THE OTHER DEVICE APPEARED TO COME STRAIGHT FROM ETHICON ENDO-SURGERY, LLC WHICH IS APPARENTLY STATIONED IN PUERTO RICO, USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25492 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, HARMONIC ACE LFL ETHICON ETHACE36E 1714851
    25493 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, HARMONIC ACE LFL ETHICON ENDO-SURGERY, LLC ACE36E K91L3T

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR