BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 2110589 · Received June 1, 2011

    Report

    Report Number
    3005075853-2011-02228
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 5, 2011
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. DURING THE ANALYSIS THE STAPLES WOULD NOT FEED, THEREFORE THE DEVICE COULD NOT BE FUNCTIONALLY TESTED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITIONS OF THE INTERNAL COMPONENTS AND THE LIFTER WAS NOTED TO BE BROKEN. IT IS POSSIBLE THAT THE TIP OF THE DEVICE WAS CONSTRAINED DURING THE PROCEDURE IN A MANNER AS TO PROHIBIT THE NATURAL MOVEMENT OF THE LIFTER, RESULTING IN THE DRIVER TO DIG AND BREAK THE LIFTER. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). 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 BILATERAL HERNIORRHAPHY PROCEDURE, THE STAPLER HAS TWENTY STAPLES HOWEVER, IT FIRED ONLY FOUR STAPLES. SO THE DEVICE WAS MISSING SIXTEEN STAPLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC MULTIFEED STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4TG92

    Patients

    Seq Age Sex Outcome Treatment
    1