BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1820759 · Received August 16, 2007

    Report

    Report Number
    1527736-2007-05415
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    June 25, 2007
    Report Date
    August 2, 2007
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE DEVICE DID NOT CUT TISSUE PROPERLY. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4H49F

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR