BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1252867 · Received December 9, 2008

    Report

    Report Number
    1527736-2008-03424
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 14, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/03/2008. 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 DISPLAYED AN ERROR CODE 7. IT WAS FOUND THAT THE HAND CONTROL SWITCH ASSEMBLY BUTTONS WERE NOT FUNCTIONAL; NO ERROR CODE 1 OR 5 WERE NOTED DURING TESTING. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATIONS 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 CHOLECYSTECTOMY, THE GENERATOR GAVE AN ERROR CODE 7, THEN GAVE AN ERROR CODE 1 AND THEN AN INSTRUMENT ERROR CODE 5. THE DEVICE WOULD NEVER WORK. SWITCHED GENERATOR AND DEVICE AND COMPLETED THE CASE. THERE WAS NO CONSEQUENCE 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 E4KP5D

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE