BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR CUTR/6 ROW BL

    MDR report key: 1822381 · Received August 16, 2007

    Report

    Report Number
    1527736-2007-05442
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    May 16, 2007
    Report Date
    July 10, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DAMAGED ARTICULATION GEAR TEETH. EVAL SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED WITH THE ARTICULATION MECHANISM DAMAGED. THE DEVICE WAS RECEIVED WITH A CARTRIDGE LOADED IN THE DEVICE; THE CARTRIDGE WAS RECEIVED UNFIRED. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE ON THE 3 ARTICULATED POSITIONS AND THE STAPLE FORMATION WAS CONFORMING. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE ARTICULATION GEAR TEETH WERE FOUND DAMAGED. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKE PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON PROCEDURE, THE DEVICE WOULD NOT STAPLE AND WOULD NOT CUT. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR CUTR/6 ROW BL GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA C4FU4T

    Patients

    Seq Age Sex Outcome Treatment
    1