BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1822227 · Received December 3, 2007

    Report

    Report Number
    1527736-2007-08208
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    June 12, 2007
    Report Date
    June 14, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE UNIT WOULD DISPLAY ERROR CODE 1 INTERMITTENTLY AT POWER-UP, AND WOULD INTERMITTENTLY FAIL TO BOOT UP DUE TO THE MAIN PCB. AFTER SERVICING THE UNIT PASSED ALL QA FUNCTIONAL TESTING. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT, THEREFORE NO SERVICE HISTORY REVIEW CAN 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 DURING AN UNK PROCEDURE, ERROR CODE 1 APPEARS ON THE SCREEN ALL THE TIME AND THE DEVICE IS NOT WORKING. THERE WAS NO PT CONSEQUENCE. ONE DEVICE RETURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HAND PIECE