BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1182742 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03760
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 30, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/17/2008. EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE MAIN PCB WAS CAUSING THE UNIT TO HAVE ERROR CODE 1 WHICH ALSO CAUSED ALL BUTTONS ON THE FRONT PANEL TO BE INOPERABLE. TO CORRECT THE COMPLAINT THE ANALYSIS SITE REPLACED THE MAIN BCB. PER THE SERVICE MANUAL, SERVICE TEST WERE PERFORMED WITH NO FUNCTIONAL FAULTS FOUND. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE GENERATOR DISPLAYED AN ERROR CODE 1 DURING AN UNK PROCEDURE. THE CUSTOMER STATED THAT AFTER ERROR OCCURRED, ALL BUTTONS ON FRONT PANEL BECAME INOPERABLE AND ERROR COULD NOT BE CLEARED. A SECOND GENERATOR WAS USED TO COMPLETE CASE WITH NO PT CONSEQUENCE.

    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 HAND PIECE