BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1820144 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07188
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    September 3, 2007
    Report Date
    September 5, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT. THE MAIN PCB BOARD AND POWER SUPPLY WERE REPLACED TO CORRECT THE ISSUE. AFTER SERVICING THE UNIT PASSED ALL QA FUNCTIONAL TESTING. 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 GENERATOR GETS SWITCHED OFF ON ITS OWN DURING OPERATION DURING A LAPAROSCOPIC COLO-RECTAL PROCEDURE. THERE WAS NO PT CONSEQUENCE. UNIT 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 HAND PIECE