BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM STAPLES

    MDR report key: 1003643 · Received February 14, 2008

    Report

    Report Number
    1527736-2008-00891
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    November 29, 2007
    Report Date
    December 6, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K913469
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NON CONFORMING CARTRIDGE 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 INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE THAT THE STAPLES WILL NOT RELEASE. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PT 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, INC. (CINCINNATI) NA D4HP19

    Patients

    Seq Age Sex Outcome Treatment
    1