BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM ARTICNG LNR CUTR/6 ROW BL

    MDR report key: 1822639 · Received November 27, 2007

    Report

    Report Number
    1527736-2007-07929
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Report Date
    October 26, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE FIRING AND CLAMPING MECHANISMS DAMAGED AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED FULLY LOADED WITH STAPLES. NO FUNCTIONAL TEST COULD BE PERFORMED WITH THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE FIRING TRIGGER TEETH AND THE YOKE TEETH WERE FOUND BROKEN. THE RETURNED CARTRIDGE WAS LOADED INTO A TEST DEVICE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. ALTHOUGH NO CONCLUSION COULD BE REACHED ON HOW THE DEVICE GOT DAMAGED WITH THE INFO PROVIDED, IT SHOULD BE NOTED THAT AT LEAST A 100% INSPECTION TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRED SPECS. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING AN UNK PROCEDURE. THE DEVICE DID NOT WORK. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM ARTICNG LNR CUTR/6 ROW BL GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1