BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1080349 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00363
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    May 16, 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
    GM
    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 GENERATOR WAS RETURNED TO THE INTERNATIONAL SERVICE CENTER. BASED UPON THE INQUIRY, INFO REC'D VISUAL AND FUNCTIONAL EXAMINATION, THE UNIT WAS FOUND TO REQUIRE: MISSING ACCESSORIES COMPLETED, REPLACE BEZEL ASSEMBLY, UNIT CALIBRATED, LABEL/OVERLAY REPLACED, MODIFIED ACCORDING TO GUIDELINE OF MFR, DEFECTIVE ELECTRICAL CONNECTOR REPLACED AND DAMAGED PCB MAIN ASSEMBLY REPLACED. 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 THE EQUIPMENT WAS SENT FOR REPAIR BECAUSE THE COOLING OF THE GENERATOR DOES NOT WORK. IT WAS NOT NOTED IF THE ISSUE OCCURRED DURING A PROCEDURE. THERE WAS NO PT CONSEQUENCE REPORTED.

    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