BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 3749175 · Received April 14, 2014

    Report

    Report Number
    3005075853-2014-02564
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    July 12, 2013
    Report Date
    March 27, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED ALONG WITH ITS PACKAGE OPENED. UPON VISUAL INSPECTION IT WAS NOTED A HOLE AT THE LOWER LEFT CORNER OF THE TYVEK AND EVIDENCE OF DRAGGING WAS NOTED AROUND THE HOLE. THE DAMAGE FOUND AT THE TYVEK OF THE PACKAGING IS RELATED TO EXTERNAL HANDLING FROM EES. ALL EES PRODUCT IS 100% INSPECTED PRIOR TO RELEASE. THE INFORMATION YOU PROVIDED IS COMPILED MONITORED AND REVIEWED BY UPPER MANAGEMENT ON A ROUTINE BASIS FOR ANY ASSOCIATED TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE THE DEVICE GETS PACKAGING INTEGRITY ISSUE. ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227913 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE