BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURG DEV, CURVED SHEARS, ENDO

    MDR report key: 727457 · Received June 19, 2006

    Report

    Report Number
    1527736-2006-02767
    Event Type
    Malfunction
    Date Received
    June 19, 2006
    Date of Event
    May 5, 2006
    Report Date
    May 12, 2006
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. THE DEVICE WAS TESTED WITH A GENERATOR AND AN ERROR CODE 5 WAS RECEIVED. THE IDENTIFIED BLADE DAMAGE MAY HAVE OCCURRED FROM EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOOKOUT" LATER IN THE PROCEDURE. THEREFORE, THE INSTRUCTIONAL INSERT STATES: "SCRATCHES ON THE BLADE MAY LEAD TO PREMATURE BLADE FAILURE" AND "AVOID ACCIDENTAL CONTACT WITH OTHER INSTRUMENTS DURING USE." THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS. 510(K) NUMBER IS K002981.

    Description of Event or Problem · 1

    DURING AN UNK PROCEDURE THAT THE DEVICE CEASED TO FUNCTION DURING THE CASE. THE DEVICE WAS CLEANED AND RETESTED-ERROR STILL PRESENTED THE HANDPIECE WAS CHANGED OVER, THE RRROR WAS STILL PRESENT. THE TEST TIP WAS USED TO VERIFY THAT IT WAS DISPOSABLE AND IT WAS. WHEN THE DISPOSABLE COMPONENT WAS CHANGED OVER THE HARMONIC COMMENCED FUNCTIONING AGAIN. THERE WAS NO ADVERSE PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION SURG DEV, CURVED SHEARS, ENDO GEI GEI ETHICON ENDO SURGERY, INC.(CINCINNATI) NA A4CC6U

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 1.GENERATOR,| 2.HAND PIECE.