BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURG DEV, CURVED SHEARS, ENDO

    MDR report key: 725997 · Received June 7, 2006

    Report

    Report Number
    1527736-2006-02599
    Event Type
    Malfunction
    Date Received
    June 7, 2006
    Report Date
    April 21, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    k002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. DUE TO THE DAMAGE TO THE BLADE, IT WAS CONFIRMED THAT THE DEVICE WAS NON-FUNCTIONAL. AN ERROR CODE 5 WAS NOTED. THE IDENTIFIED 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." (510(K)#K002981)

    Description of Event or Problem · 1

    DURING A LAP SIGMA PROCEDURE, AFTER 10 MINUTES, ERROR CODE. TOOK NEW INSTRUMENT. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GENERATOR| HANDPIECE