BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 3850298 · Received June 5, 2014

    Report

    Report Number
    3005075853-2014-03733
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH TISSUE PAD DETACHED AND RETURNED 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. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, AS THE SURGEON WAS USING DEVICE, THE INSULATION WHICH RUNS ALONG THE JAWS OF THE SCALPEL DETACHED. THE INSULATION WAS RETRIEVED FROM PATIENT AND TAPED AND RETAINED WITH DEVICE FOR ATTENTION OF THE SALES REP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329590 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE