BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2943448 · Received February 5, 2013

    Report

    Report Number
    3005075853-2013-00465
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 21, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE TISSUE PAD MELTED AND PARTIALLY DETACHED, WITH THE BLADE TIP INTACT AND NOT BROKEN OFF AS REPORTED BY THE CUSTOMER. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND IT DID ACTIVATE DURING FUNCTIONAL TESTING. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. AVOID ACTIVATING THE BLADE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO PREVENT DAMAGE TO THE TISSUE PAD. BECAUSE THE BLADE WAS NOT RETURNED BROKEN AS REPORTED, IT IS POSSIBLE THAT THE DEVICE RETURNED MAY HAVE BEEN USED TO COMPLETE THE PROCEDURE AND IS NOT THE DEVICE COMPLAINED ABOUT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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 A LAPAROSCOPIC LIVER RESECTION PROCEDURE THE BLADE TIP BROKEN OFF. THE TIP DID NOT BREAK OFF INTO THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. ONE DEVICE TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47565 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J4CD7U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE