BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1080017 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00573
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Report Date
    July 7, 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 Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/17/2008. BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE EQUIPMENT WAS RETURNED TO THE SERVICE CENTER. BASED UPON THE INQUIRY INFORMATION RECEIVED, VISUAL AND FUNCTIONAL EXAMINATION, THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. TO CORRECT THE CUSTOMER COMPLAINT, THE MAIN PCB ASSEMBLY WAS REPLACED. THE DATABASE WAS REVIEWED AND NO PRIOR SERVICING HISTORY WAS FOUND, THEREFORE, NO SERVICE HISTORY REVIEW COULD BE DONE. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EQUIPMENT WAS SENT TO THEM FOR REPAIR BECAUSE THE GENERATOR WOULD NOT BOOT UP. IT WAS NOT NOTED IF THE ISSUE OCCURRED DURING A PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL GENERATOR LFL ETHICON ENDO-SURGERY, LLC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1