BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1081067 · Received July 21, 2008

    Report

    Report Number
    3005075853-2008-00584
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 25, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAVH PROCEDURE, THE TISSUE PAD CAME OFF BUT WAS FOUND OUTSIDE OF THE PATIENT. THIS OCCURRED AT THE END OF THE PROCEDURE AND ANOTHER DEVICE WAS NOT NEEDED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC NA E4L409

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE