BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1112776 · Received August 12, 2008

    Report

    Report Number
    3005075853-2008-01112
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/12/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP PROSTATECTOMY PROCEDURE, THE DEVICE WAS ACTIVATED THREE TIMES AND THEN THE TISSUE PAD FELL OFF. THE SURGEON RETRIEVED THE TISSUE PAD FROM INSIDE THE PATIENT AND OPENED A NEW DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC. NA E4KL88

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE