BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23 CM

    MDR report key: 1150959 · Received August 28, 2008

    Report

    Report Number
    3005075853-2008-01422
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    August 8, 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

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RADICAL PROSTATECTOMY PROCEDURE, THE TEFLON PAD BECAME LOOSE, AND FELL INTO THE PATIENT. IT WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23 CM LFL ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR