BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1191315 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03670
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    February 24, 2008
    Report Date
    May 16, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD MELTED AND PARTIALLY DETACHED. NO ACTIVATION ISSUES WERE NOTED DURING TESTING WITH THE GENERATOR. BASED ON THE CONDITION OF THE TISSUE PAD, IT APPEARS POSSIBLE THAT THE CLAMP OF THE DEVICE MAY HAVE BEEN CLOSED AND THE INSTRUMENT ACTIVATED WITHOUT TISSUE PRESENT. THIS DAMAGE OCCURS WHEN THE INSTRUMENT IS ACTIVATED WITHOUT TISSUE PRESENT. OUR INSTRUCTION INSERT STATES: "CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. THIS CAN RESULT IN POSSIBLE DAMAGE TO THE INSTRUMENT." BOTH CONDITIONS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER OF THE FOOT PEDALS IS DEPRESSED AND KEEP THE CLAMP ARM OPEN WHEN BACKCUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. COMPLAINT INFO 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 MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PANCREATECTOMY PROCEDURE, THE DEVICE STOPPED WORKING. UNK HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM NONE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE