BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1080519 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00425
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    June 18, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SIGMOID PROCEDURE, THE TEFLON PAD FELL INTO THE PT. THE PAD WAS RETRIEVED AND REMOVED FROM THE BODY. THERE IS NO FURTHER INFO AVAILABLE. THE PROCEDURE WAS COMPLETED BY PULLING A LIKE DEVICE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM NONE LFL ETHICON ENDO-SURGERY, LLC NA E4KA8K

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR