BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 3903469 · Received June 30, 2014

    Report

    Report Number
    3005075853-2014-04509
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 23, 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). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLADE TIP BROKE OFF. THE PIECE DIDN'T FALL INTO PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO DEVICE WILL BE RETURNED AS THEY DON'T HAVE THE DEVICE ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379419 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE