BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURG DEV, CURVED SHEARS, OPEN

    MDR report key: 725932 · Received June 7, 2006

    Report

    Report Number
    1527736-2006-02594
    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

    ANALYSIS SUMMARY: BASED ON ANALYSIS RESULT, 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 INDENTIFIED BLADE DAMAGE MAY HAVE OCCURRED FORM EXTERNAL CONTACT DURING PRE-OP GENERAL USE. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEUDRE. THEREFORE, THE INSTRUCTIONAL INSERT STATES: "SCRATCHES ON THE BLADE MAY LEAD TO THE 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)#K002981)

    Description of Event or Problem · 1

    PRIOR TO A STRUMA PROCEDURE, THE INSTRUMENT DID NOT FUNCTION. ANOTHER DEVICE 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, CURVED SHEARS, OPEN GEI LFL ETHICON ENDO SURGERY, INC.(CINCINNATI) NA A4C819

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GENERATOR| HANDPIECE