BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1190929 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03529
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    February 25, 2008
    Report Date
    April 9, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RECEIVED IN GOOD CONDITION. NO VISISBLE DAMAGE WAS NOTED. THE FIRST 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. THE CUTTING TEST MEDIA PERFORMED AS EXPECTED, NO ANOMALIES NOTED. WITH THE SECOND DEVICE, 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 MAX BUTTONS WERE FUNCTIONAL. THE FOOTSWITCH PEDAL WAS USED TO ACTIVATE THE INSTRUMENT. IT WAS FUNCTIONALLY EVALUATED WITH A TEST MEDIA AND NO ANOMALIES WERE NOTED WHILE CUTTING. NO TISSUE EFFECT ISSUES WERE NOTED. 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 SIGMOIDECTOMY PROCEDURE, THE DEVICES HAD DIFFICULTY OF CUTTING AND COAGULATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. 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