BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM STAPLES

    MDR report key: 1083036 · Received July 23, 2008

    Report

    Report Number
    3005075853-2008-00637
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K913469
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOSE WELD. EVALUATION SUMMARY: THE ANALYSIS RESULTS SHOWED THAT ONE EMS DEVICE WAS RETURNED WITH THE NOSE OPEN AND NON-FUNCTIONAL DUE TO AN INSUFFICIENT CARTRIDGE NOSE WELD. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE DEVICE HAD "JAMMED STAPLES." THERE IS NO ADDITIONAL INFORMATION AVAILABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM STAPLES GCJ ETHICON ENDO-SURGERY, LLC NA E4K45R

    Patients

    Seq Age Sex Outcome Treatment
    1