BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1823841 · Received December 12, 2007

    Report

    Report Number
    1527736-2007-08465
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Date of Event
    November 13, 2007
    Report Date
    November 14, 2007
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND TO CORRECT THE COMPLAINT THE MAIN PC BOARD WAS REPLACED. 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 PRIOR TO AN UNKNOWN PROCEDURE THE GENERATOR EMITTED A SOLID TONE DURING THE USE. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNED TO THE INTERNATIONAL SERVICE CENTER.

    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 HANDPIECE