BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 6300497 · Received February 3, 2017

    Report

    Report Number
    3005075853-2017-00708
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    January 30, 2017
    Report Date
    January 30, 2017
    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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # K90606. THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED, MELTED, NOT ALL PRESENT AND A HALF PORTION WAS NOT RETURNED. IN ADDITION, THE TISSUE PAD WAS ATTACHED TO THE CLAMP ARM AND NOT DETACHED AS REPORTED BY THE CUSTOMER. THE DEVICE WAS CONNECTED TO A TEST HAND PIECE AND A GEN11, DURING FUNCTIONAL TESTING IT WAS NOTED THAT THE HAND ACTIVATION BUTTONS WERE NONFUNCTIONAL. HOWEVER, THE DEVICE DID ACTIVATE WHEN TESTED WITH THE FOOT SWITCH. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. CORROSION WAS FOUND AT THE HAND ACTIVATION DOMES. DUE TO THE MOISTURE DISCOVERED ON THE INSTRUMENT WHICH IS EVIDENCE OF POSSIBLE REUSE, WE ARE UNABLE TO DETERMINE HOW THIS CONDITION IMPACTED THE PERFORMANCE OF THE DEVICE AND THEREFORE CANNOT CONCLUDE ROOT CAUSE. OUR MANUFACTURING, STERILIZATION, PACKAGING, AND SHIPMENT PROCESSES DO NOT INTRODUCE CORROSION / MOISTURE TO THE DEVICE. PLEASE NOTIFY US OF ANY PROCESSES OR CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE MOISTURE IN THE INSTRUMENT. THE BATCH HISTORY RECORD WAS REVIEWED AND THERE WERE NO DEFECTS, PROTOCOLS OR NCR(S) FOUND DURING THE MANUFACTURING PROCESS RELATED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON WAS USING THE NEW DEVICE AND AFTER USE OF FEW MINUTES THE TISSUE PAD WAS REMOVED FROM THE JAW. THEN HE USED ANOTHER NEW PROBE AND COMPLETED THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82559 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA K90606

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE