BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE + 7

    MDR report key: 4243760 · Received November 11, 2014

    Report

    Report Number
    3005075853-2014-07830
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 30, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K132612
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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, CUT THE TEST MEDIA, AND TONE AS EXPECTED. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. PROLONGED USAGE OF ADVANCED HEMOSTASIS MODE MAY CAUSE TISSUE PAD DAMAGE. KEEP THE CLAMP ARM OPEN WHEN BACKCUTTING 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. IT COULD NOT BE DETERMINED WHY THE DEVICE REPORTED REPLACE INSTRUMENT ALERT. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. IT IS POSSIBLE THAT THE ISSUE ENCOUNTERED WAS DUE TO THE HP054 HANDPIECE CONTACTS BEING DIRTY. IT IS RECOMMENDED THAT THE HAND PIECE GOLD CONTACTS BE CLEANED PERIODICALLY OR WHEN DIRTY. FAILURE TO DO SO CAN RESULT IN NO HAND ACTIVATION FUNCTION.

    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. EVENT DATE - ONLY YEAR KNOWN, ASSUMED ((B)(6) 2104) THAT COMPLAINT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TISSUE PAD WAS LOOSE. PART OF THE TISSUE PAD FELL INTO THE PATIENT, BUT COULD BE REMOVED. THE GENERATOR DISPLAYED REPLACE INSTRUMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727734 HARMONIC ACE + 7 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE