BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1182545 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03661
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/11/2008. BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT. BASED UPON THE INQUIRY INFO RECEIVED, VISUAL AND FUNCTIONAL EXAMINATION, THE UNIT WAS FOUND TO REQUIRE REPLACEMENT OF THE GENERATOR PCB. TESTING INCLUDED: CALIBRATION I, CALIBRATION II, ELECTRICAL SAFETY TEST, AND RELEASE TEST. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED VIA THE DATABASE. THE UNIT HAS PASSED ALL QA INSPECTIONS. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNK PROCEDURE, THE DEVICE COULD NOT WORK. AN ERROR CODE "1" DISPLAYED. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE