BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2982547 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00911
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 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
    JA
    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). ADDITIONAL INFORMATION: AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED ADDITIONAL INFORMATION 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. BOTH CONDITIONS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER OF THE FOOT PEDALS IS DEPRESSED. 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 A LAVH, THE TISSUE PAD WAS DAMAGED AND PARTIALLY DETACHED OFF. AS THE FRAGMENT WAS SHOWN ON SCREEN, THE SURGEON NOTICED THE TISSUE PAD WAS DAMAGED. THE FRAGMENT FOUND ON SCREEN WAS RETRIEVED FROM THE PATIENT. ALSO, A NURSE FOUND ANOTHER FRAGMENT ON GAUZE. ALTHOUGH IT SEEMED THAT THERE WAS NO MISSING PART OF THE TISSUE PAD, THE ABDOMINAL CAVITY WAS IRRIGATED THOROUGHLY WITH MORE THAN 2000CC WATER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE DOCTOR COMMENTED THAT NO PIECES WERE LEFT INSIDE THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE OPERATION WAS LONG AND THE DEVICE WAS ACTIVATED WITHOUT HAVING TISSUE BETWEEN THE BLADE AND THE TISSUE PAD. ALSO, THE TISSUE PAD WAS WIPED MULTIPLE TIMES WITH GAUZE BY A NURSE. THE SALES REP INSERVICED TO THE OPERATION STAFF ABOUT THE USAGE OF THE HARMONIC INSTRUMENT AGAIN. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87551 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J91J80

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE