BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1150958 · Received August 28, 2008

    Report

    Report Number
    3005075853-2008-01423
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 8, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT DEVICES A AND B WERE RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICES WERE TESTED WITH A GEN04 AND WERE FUNCTIONAL. THE HAND ACTIVATION ASSEMBLY BUTTONS WORKED AS INTENDED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICES. IT COULD NOT BE DETERMINED WHY THE DEVICES REPORTEDLY MALFUNCTIONED. WHILE WE WERE UNABLE TO RECREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WAS ACTIVATED, AND THE SWITCH BUTTON WAS WORKING INTERMITTENTLY. THEY USED A SECOND DEVICE AND THE SAME ISSUE OCCURRED. THEY USED A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC NA E4L54U

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR