BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23CM

    MDR report key: 1810001 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07556
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 18, 2007
    Report Date
    October 23, 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
    JA
    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 AN UNK PROCEDURE, AN ERROR OCCURRED. THE DEVICE WAS USED AT FIRST, AND AFTER TAKING OUT OF THE PT'S BODY, IT WAS FOUND THAT THE BLADE WAS BROKEN. THE SURGEON CHECKED AND CONFIRMED THAT IT WAS NOT INSIDE THE BODY BY THE X-RAY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23CM LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR