BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1182586 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03684
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 12, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/12/2008. BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE UNIT WAS RETURNED TO THE INTERNATIONAL SERVICE CENTER. BASED UPON THE INQUIRY INFO RECEIVED, VISUAL AND FUNCTIONAL EXAMINATION, THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. TO CORRECT THE ISSUE, THE MAIN PCB WAS REPLACED. TESTING INCLUDED: CALIBRATION 1&2, POWER CALIBRATION, ELECTRICAL SAFETY TESTS, QA TEST. THE DATABASE WAS REVIEWED AND NO PRIOR SERVICING HISTORY WAS FOUND, THEREFORE, NO SERVICE HISTORY REVIEW COULD BE DONE. 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, GENERATOR ERROR WAS RECEIVED. IT WAS NOT NOTED HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT REPORTED.

    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