BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LFL INSTRUMENT, ULTRASONIC SURGICAL

    MDR report key: 1460599 · Received May 19, 2009

    Report

    Report Number
    3005075853-2009-02909
    Event Type
    Malfunction
    Date Received
    May 19, 2009
    Date of Event
    April 22, 2009
    Report Date
    April 24, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 5/19/2009. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, THE TRIGGER OF THE DEVICE WAS NOT RETURNED AFTER PRESSING. UNK HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LFL INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC NA D4H241

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR