BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23 CM

    MDR report key: 1182576 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03675
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/11/2008. THE ANALYSIS FOUND THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD MISSING. AS THE TISSUE PAD WAS NOT RETURNED. THE DEVICE WAS TESTED ON THE GENERATOR AND NO TEMPERATURE ISSUES WERE NOTED. HOWEVER, SINCE THE DEVICE IS MISSING THE TISSUE PAD, THE CONTACT OF METAL TO METAL MAY LEAD TO OCCURRED NOISE ISSUES. THE REPORTED ISSUE OF SMOKING MAY HAVE BEEN A RESULT OF THE TISSUE PAD MELTING OR THE BURNING OF TISSUE BUILDUP BETWEEN THE BLADE AND SHAFT. OUR INSTRUCTION FOR USE ADVISES: BLOOD AND TISSUE BUILDUP BETWEEN THE BLADE AND SHAFT MAY RESULT IN ABNORMALLY HIGH TEMPERATURES AT THE DISTAL END OF THE SHAFT. 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. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE SHAFT WAS TOO HOT AND THE SMOKE REEKED UP A LOT. ALSO, THERE WAS A RUSTLING OF METALLIC. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23 CM NONE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4K59Y

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR