BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1070561 · Received July 2, 2008

    Report

    Report Number
    3005075853-2008-00261
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/02/2008. TISSUE PAD ISSUE. EVAL 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE, THE ENTIRE WHITE PAD CAME OFF OF THE DEVICE. NO PIECE FELL INTO THE PATIENT. THEY USED A SECOND LIKE DEVICE TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC. NA E4L03R

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE