BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 2232176 · Received September 2, 2011

    Report

    Report Number
    3005075853-2011-03368
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K913469
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): LIFTER AND NONCONFORMING CRIMP ASSEMBLY. THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE WAS RETURNED NON-FUNCTIONAL; THE DEVICE WAS RETURNED WITH THE CARTRIDGE EXTENDING OUT FROM THE TUBE. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED AND AN INSUFFICIENT CRIMP WAS NOTED 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). 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 SURGEON INDICATED THE STAPLE DID NOT DEPLOY. ANOTHER DEVICE WAS PULLED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC MULTIFEED STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GDW ETHICON ENDO-SURGERY, LLC. NA H43E9G

    Patients

    Seq Age Sex Outcome Treatment
    1