BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1182590 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03689
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 1, 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. EVAL SUMMARY- 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 AND THE POWER SUPPLY WERE REPLACED. ALSO THE BEZEL SUB ASSEMBLY WAS REPLACED. TESTING INCLUDED: CALIBRATION 1 & 2, POWER CALIBRATION, ELECTRICAL SAFETY TESTS, QA 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 DURING AN UNK PROCEDURE, BLINKING OF GENERATOR INDICATORS ON START-UP. IT WAS UNK HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    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