BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1080352 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00369
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    June 19, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER'S COMPLAINT AND FOUND THE BEZEL READY LIGHT WAS NOT FUNCTIONAL AND THE UNIT DIDN'T LEAVE TEST MODE WITH ALL HAND PIECES. TO CORRECT THE COMPLAINT, THE ANALYSIS SITE REPLACED THE BEZEL AND THE MAIN PCB. PER SERVICE MANUAL PERFORMED CALIBRATION AND TEST WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE STANDARD SERVICE PROCESS CHANGED THE EPROM VERSION. 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 THE GENERATOR WAS NOT WORKING AND HAD A DAMAGED FACEPLATE. THERE WERE NO CASE DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL GENERATOR NONE LFL ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HAND PIECE