BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1003647 · Received February 14, 2008

    Report

    Report Number
    1527736-2008-00883
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 23, 2008
    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

    DATE SENT: 2/14/2008. HAND CONTROL BUTTON NON FUNCTIONAL. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED IN GOOD CONDITION. NO VISIBLE DAMAGE WAS NOTED. THE HAND-ACTIVATION CONTACTS WERE IN GOOD CONDITION. THE DEVICE WAS TESTED ON A GENERATOR AND IT WAS FOUND THAT THE HAND CONTROL SWITCH ASSEMBLY BUTTONS WERE NOT FUNCTIONAL. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE HANDSWTICH COULD NOT BE USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4JD6F

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE