BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

    MDR report key: 725940 · Received June 7, 2006

    Report

    Report Number
    1527736-2006-02595
    Event Type
    Malfunction
    Date Received
    June 7, 2006
    Report Date
    April 21, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    KNS
    PMA / PMN Number
    k990362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS DETERMINED TO BE A MDR MALFUNCTIONS. 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 INDENTIFIED BLADE DAMAGE MAY HAVE OCCURRED FORM 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 "LOCKOUT" 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 MANUFACTURING PROCESS. (510(K)#K990362)

    Description of Event or Problem · 1

    DURING A CHOLECYSTECTOMY PROCEDURE, AFTER 5 TIMES NO FUNCTION, ERROR CODE ON DISPLAY. A NEW INSTRUMENT WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN GEI KNS ETHICON ENDO SURGERY, INC.(CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN HANDPIECE| GENERATOR