BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3943908 · Received July 18, 2014

    Report

    Report Number
    3005075853-2014-05077
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DEVICE WAS REPROCESSED THE DEVICE WAS RETURNED WITH TISSUE PAD DETACHED BUT WITH EVIDENCE OF THE TISSUE PAD MATERIAL IN THE GROOVE SECTION OF THE CLAMP ARM. DURING THE VISUAL INSPECTION OF THE INSTRUMENT, IT WAS NOTED THAT THE CLAMP ARM WAS DAMAGED. WHEN THE DEVICE WAS CONNECTED TO THE GENERATOR AN ALERT SCREEN WAS DISPLAYED. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS AND CORROSION WAS FOUND AT THE ELECTRICAL TRACES AND DOMES OF THE HAND ACTIVATION BUTTONS. DUE TO THE CORROSION DISCOVERED ON THE INSTRUMENT WHICH IS EVIDENCE OF POSSIBLE REUSE/REPROCESSING, WE ARE UNABLE TO DETERMINE HOW THIS CONDITION IMPACTED THE PERFORMANCE OF THE DEVICE AND THEREFORE CANNOT CONCLUDE ROOT CAUSE. OUR MANUFACTURING, STERILIZATION, PACKAGING, AND SHIPMENT PROCESSES DO NOT INTRODUCE CORROSION / MOISTURE TO THE DEVICE. THE DEVICE HAS BEEN REPROCESSED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION - 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 WHITE TISSUE PAD FELL OFF WHEN IT WAS USED FOR THE FIRST TIME. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421852 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE