BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1252945 · Received December 9, 2008

    Report

    Report Number
    1527736-2008-03440
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 11, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/03/2008. EVAL SUMMARY: 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, THE INSTRUMENT ACTIVATED THE GENERATOR USING THE FOOTSWITCH PEDAL. 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 AN UNK PROCEDURE, THE DEVICE WOULD NOT PASS THE PRE-TEST. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM NONE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4K476

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR