BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 3972807 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05395
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 22, 2014
    Report Date
    July 23, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. DEVICE EVALUATION - NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. 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: 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 WITH DIFFICULTY. DURING MECHANICAL TESTING, THE ROTATION KNOB DID NOT ROTATE FREELY. THE DEVICE WAS THEN FUNCTIONALLY TESTED ON THE GEN11 GENERATOR. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED. THE DAMAGED HAND ACTIVATION CONTACTS COULD CAUSE ROTATIONAL ISSUES WITH THE DEVICE. IN ADDITION, IT CAN CAUSE IMPROPER TORQUE OF THE BLADE, WHICH COULD CAUSE THE GENERATOR TO DISPLAY COMMUNICATION OR ACTIVATION ISSUES AND ALERT SCREENS. TO AVOID DAMAGING THE CONTACTS, IT IS RECOMMENDED TO ASSEMBLE THE DEVICE VERTICALLY. HAND SWITCH CONTACTS DAMAGED DUE TO TILTED HANDPIECE HITTING CONTACT TOP SURFACE DURING ASSEMBLY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HIATAL HERNIA PROCEDURE, THE TISSUE PAD BURNT OFF. RETRIEVED WITH A GRASPER. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450750 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE