BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1210235 · Received October 21, 2008

    Report

    Report Number
    3005075853-2008-02501
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 30, 2008
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/21/2008. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD MISSING. AS THE TISSUE PAD WAS NOT RETURNED, FURTHER EVALUATION COULD NOT BE PERFORMED. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THIS INSPECTION AND TESTING. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY. THE TISSUE PAD FELL OFF. THE LOCATION OF THE TISSUE PAD IS UNK. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE