BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1003667 · Received February 14, 2008

    Report

    Report Number
    1527736-2008-00916
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Report Date
    January 23, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SIGMA PROCEDURE ACTIVE BLADE BROKEN IN THE MIDDLE OF THE BLADE PART FELL INTO THE PT COULD BE REMOVED. NO ERROR CODE ON DISPLAY. NO FURTHER INFO AVAILABLE. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36CM-15MM ACTIVE BL GEI ETHICON ENDO-SURGERY, INC. NA D4H53K

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR