BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS LONG 5MM CURVED SHEARS

    MDR report key: 1163334 · Received September 10, 2008

    Report

    Report Number
    3005075853-2008-01627
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    March 6, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND MISSING. THE REMAINING BLADE PORTION WAS SCRATCHED. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. THE REPORTED COMPLAINT WAS FOR AN ACTIVATION ISSUE. A POSSIBLE CAUSE OF AN ACTIVATION ISSUE IS BLADE DAMAGE. BLADE DAMAGE IS CAUSED BY CONTACTING AN ACTIVE BLADE WITH OTHER SURGICAL DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY RESULT IN FATIGUE FAILURE INITIATING AT THE ORIGINAL DAMAGE LOCATION, WHICH CAN RESULT IN THE BLADE TIP BREAKING OFF AS DESCRIBED ABOVE. EACH DEVICE IS VISUALLY INSPECTED AN FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE STOPPED WORKING AFTER 6 HOURS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS LONG 5MM CURVED SHEARS GEI ETHICON ENDO-SURGERY, LLC NA D4GV51

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE