BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1081070 · Received July 21, 2008

    Report

    Report Number
    3005075853-2008-00581
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 25, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOIDECTOMY PROCEDURE, THE TISSUE PAD OF THE DEVICE DETACHED. THE TISSUE PAD WAS RECOVERED. THE PROCEDURE WAS COMPLETED WITH A SAME LIKE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC NA E4KH7F

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE