BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1860044 · Received October 7, 2010

    Report

    Report Number
    3005075853-2010-05693
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 17, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE TISSUE PAD PARTIALLY DETACHED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND THE DEVICE ACTIVATED WHEN FUNCTIONALLY TESTED.. THE CLAMP OPENED AND CLOSED; NO MISALIGNMENT WAS NOTED BETWEEN THE DISTAL TIP OF THE BLADE AND THE CLAMP ARM WHEN IT WAS CLOSED. BASED ON THE CONDITION OF THE TISSUE PAD, A POSSIBLE 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 BACKCUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. THE PARTIALLY DETACHED TISSUE PAD IS NOT RELATED TO THE REPORTED ISSUE OF JAWS NOT ALIGNING PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PARTIAL GASTRECTOMY PROCEDURE, THE JAWS ON THE DEVICE ARE NOT ALIGNING PROPERLY. THE DEVICE WAS USED A COUPLE OF TIMES IN THE CASE AND THE JAWS WERE NOTICED TO NOT BE ALIGNED. THE DEVICE WAS NOT REPROCESSED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE