BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 4173768 · Received October 15, 2014

    Report

    Report Number
    3005075853-2014-07100
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    July 7, 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 Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH TISSUE PAD DETACHED BUT WITH EVIDENCE OF THE TISSUE PAD MATERIAL IN THE GROOVE SECTION OF THE CLAMP ARM. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND THE DEVICE DID ACTIVATE DURING FUNCTIONAL TESTING. BASED ON THE CONDITION OF THE TISSUE PAD, A PROBABLE CAUSE FOR THIS DAMAGE IS THAT THE CLAMP OF THE DEVICE MAY HAVE BEEN CLOSED AND THE INSTRUMENT ACTIVATED WITHOUT TISSUE PRESENT. CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. KEEP THE CLAMP ARM OPEN WHEN BACK-CUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. THE RESULTING DAMAGE CONTRIBUTES TO THE REMOVAL OF THE PAD FROM THE CLAMP ARM. CLEANING OF THE PAD, NOT IN ACCORDANCE WITH THE IFU CAN ALSO RESULT IN REMOVAL OF THE PAD DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TEFLON PAD OF THE ACE36E MELTED. CUSTOMER HAS CHANGED THE INSTRUMENT BECAUSE THERE WAS A RISK OF BURNINGS FOR THE PATIENT. THE CASE WAS COMPLETED BY USING ANOTHER ACE36E. CUSTOMER CANNOT PROVIDE ANY MORE DETAILS ABOUT THE CIRCUMSTANCES IN WHICH THE ISSUE OCCURRED. NO PATIENT CONSEQUENCE WAS REPORTED. ONE DEVICE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656027 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE