BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23CM W ERG HANDLE

    MDR report key: 1231185 · Received November 10, 2008

    Report

    Report Number
    3005075853-2008-02892
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 16, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BUTTONS WERE INTERMITTENTLY WORKING AND THEN THE MIN BUTTON WAS NOT WORKING AT ALL. THE DEVICE WAS REASSEMBLED. HOWEVER, THE DEVICE KEPT GIVING AN ERROR CODE 5. SURGERY WAS PROLONGED 20 MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23CM W ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC NA E4LD48

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE