BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS HAND CONTROLLED CURVED SHEA

    MDR report key: 1823647 · Received November 16, 2007

    Report

    Report Number
    1527736-2007-07782
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Report Date
    October 8, 2007
    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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: TWO DEVICES (A-B) WERE RETURNED FOR ANALYSIS. BOTH DEVICES WERE 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 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 "LOCKOUT" LATER IN THE PROCEDURE. THEREFORE, THE INSTRUCTIONAL INSERT STATES: "AVOID ACCIDENTAL CONTACT WITH ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. CONTACT WITH STAPLES, CLIPS OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY GENERATOR SOLID TONE OR INSTRUMENT ERROR." EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICES DID NOT WORK FROM THE BEGINNING. THE ERROR CODE "SHEARS DEFECT" APPEARED AT THE SCREEN. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS HAND CONTROLLED CURVED SHEA GEI ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HF0W

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR