BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 3833814 · Received May 27, 2014

    Report

    Report Number
    3005075853-2014-03578
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 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 RECEIVED WITH THE TISSUE PAD IN GOOD CONDITIONAL AND PROPERLY ATTACHED TO THE CLAMP ARM (NOT DETACHED AS REPORTED BY THE CUSTOMER). THE HAND ACTIVATIONS CONTACTS WERE BENT. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE WITH DIFFICULTY. DURING MECHANICAL TESTING, THE ROTATION KNOB DID NOT ROTATE FREELY. THE DEVICE WAS THEN FUNCTIONALLY TESTED ON THE GEN11 GENERATOR. DURING FUNCTIONAL TESTING, NO ALERT SCREENS WERE DISPLAYED. THE DAMAGED HAND ACTIVATION CONTACTS COULD CAUSE ROTATIONAL ISSUES WITH THE DEVICE. IN ADDITION, IT CAN CAUSE IMPROPER TORQUING OF THE BLADE, WHICH COULD CAUSE THE GENERATOR TO DISPLAY COMMUNICATION OR ACTIVATION ISSUES AND ALERT SCREENS. TO AVOID DAMAGING THE CONTACTS, IT IS RECOMMENDED TO ASSEMBLE THE DEVICE VERTICALLY. HAND SWITCH CONTACTS DAMAGED DUE TO TILTED HANDPIECE HITTING CONTACT TOP SURFACE DURING ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. 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 DURING AN UNKNOWN PROCEDURE, THE INSTRUMENT HAD THE TISSUE PAD DETACHED. CUSTOMER CANNOT PROVIDE ANY MORE DETAILS ABOUT THE CIRCUMSTANCES IN WHICH THE ISSUE OCCURRED. NO PATIENT CONSEQUENCE WAS REPORTED. THE TISSUE PAD DETACHED FROM THE CLAMP ARM AND FALL OFF NO PIECE FELL INTO THE PATIENT. ONE DEVICE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310830 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE