BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1082911 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00676
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 1, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD MISSING. AS THE TISSUE PAD WAS NOT RETURNED, FURTHER EVAL 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. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, 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 TOTAL GASTRECTOMY PROCEDURE, THE TISSUE PAD CAME OFF OUTSIDE THE BODY. 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 36 CM LFL ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR