BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1081064 · Received July 21, 2008

    Report

    Report Number
    3005075853-2008-00587
    Event Type
    Malfunction
    Date Received
    July 21, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE BLADE OF THE DEVICE WAS BROKEN AND PART OF IT FELL INTO THE PATIENT. THE BLADE FRAGMENT WAS REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC. NA E4KK9W

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR