BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1080005 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00544
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Report Date
    July 4, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE GENERATOR WAS RECEIVED AT THE INTERNATIONAL SERVICE CENTER. THE COMPLAINT HAS BEEN CONFIRMED. BASED UPON THE INQUIRY INFORMATION. RECEIVED VISUAL AND FUNCTIONAL EXAMINATION, THE UNIT WAS FOUND TO REQUIRE REPLACEMENT OF THE GENERATOR PCB ASSEMBLY. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED VIA THE DATABASE. THE UNIT HAS PASSED ALL QA INSPECTIONS. 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 FOR REPAIR DUE TO AN ERROR CODE 5 GOES OFF FREQUENTLY AND THE ALARM GOES OFF OFTEN WITHOUT ANYTHING SHOWING ON THE DISPLAY. 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 HAND PIECE