BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3942329 · Received July 17, 2014

    Report

    Report Number
    3005075853-2014-05062
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 11, 2014
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DEVICE WAS REPROCESSED THE BLADE WAS NOTED TO HAVE DAMAGE IN THE FORM OF SCUFF/SCRATCHES AS IF CLEANED WITH A METAL PAD. IN ADDITION IT WAS NOTED THAT THE TISSUE PAD DETACHED AND A 4-40 STUD WAS BROKEN AND STUCK ON THE DEVICE. DUE TO THE BLADE DAMAGE ON THE INSTRUMENT WHICH IS EVIDENCE OF POSSIBLE REUSE/REPROCESSING, 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 BLADE DAMAGE OF THIS TYPE TO THE DEVICE. THE DEVICE WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS. CORROSION WAS FOUND AT THE HAND ACTIVATION DOMES. DUE TO THE MOISTURE DISCOVERED ON THE INSTRUMENT WHICH IS EVIDENCE OF POSSIBLE REUSE/REPROCESSING, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TISSUE PAD FELL OFF. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418974 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE