BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC HANDPIECE - FOR USE WITH 115 VOLT GENERATOR

    MDR report key: 1058695 · Received June 3, 2008

    Report

    Report Number
    1527736-2008-03433
    Event Type
    Injury
    Date Received
    June 3, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K990430
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/03/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION, THE DEVICE WAS MALFUNCTIONING AND CAUSED SOME BLEEDING. CONVERTED TO AN OPEN PROCEDURE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC HANDPIECE - FOR USE WITH 115 VOLT GENERATOR LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR