BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36 CM - 15 MM ACTIV

    MDR report key: 1821024 · Received October 9, 2007

    Report

    Report Number
    1527736-2007-06688
    Event Type
    Malfunction
    Date Received
    October 9, 2007
    Date of Event
    September 3, 2007
    Report Date
    October 3, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FUNDOPLICATION PROCEDURE, THE DEVICE WAS CUTTING TOO SLOWLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36 CM - 15 MM ACTIV GEI ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HJ6K

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE