BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3232117 · Received July 17, 2013

    Report

    Report Number
    3005075853-2013-03600
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 28, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED AND WITH A SMALL PART NOT RETURNED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GEN11 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

    Description of Event or Problem · 1

    PER USER FACILITY MEDWATCH FORM, (B)(4), DURING AN ABDOMINAL SURGERY PROCEDURE (WHICH WAS INITIATED AS A LAPAROSCOPIC, HOWEVER DUE TO THE COMPLEXITY AN ABDOMINAL INCISION NEEDED TO BE MADE); THE SURGEON WAS USING THE HARMONIC SCALPEL AND NOTED THAT A PIECE OF THE "JAW" WAS OFF. THE PIECE WAS RETRIEVED. UNABLE TO DETERMINE IF THE PIECE WAS OFF WHEN REMOVED FROM THE PACKAGE OR NOT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332515 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J92M94

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR GENERATOR, HANDPIECE