BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1252943 · Received December 9, 2008

    Report

    Report Number
    1527736-2008-03437
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 19, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. HOWEVER, IT WORKED PROPERLY WITH FOOT SWITCH ASSEMBLY. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. OUR MFG BATCH HISTORY REVIEW IDENTIFIED THAT THE "MAX OR MIN ACTIVATION BUTTON FAILS TO ACTIVATE GENERATOR OR ACTIVATION IS INTERMITTENT" ISSUE WAS DETECTED DURING THE MFG OF ONE OF THESE LOTS. WHEN THIS OCCURS, OUR QUALITY SYSTEM DOCUMENTS THE NECESSARY ACTIONS TO ENSURE FINAL PRODUCT QUALITY. THE FINAL RELEASE CRITERIA WAS MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY, THE DEVICE FAILED. ANOTHER DEVICE WAS USED TO COMPLETE 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 D4JT13

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE