BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7024430 · Received November 13, 2017

    Report

    Report Number
    1219930-2017-08697
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 16, 2017
    Report Date
    January 8, 2018
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    30884523003219
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE RELOAD HAD A FULL STAPLE COMPLEMENT. FUNCTIONALLY THE RELOAD WAS LOADED INTO A PMV REPRESENTATIVE INSTRUMENT AND WAS APPLIED TO TEST MEDIA WITH PROPER STAPLE PLACEMENT AND MEDIA TRANSECTION. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MANUFACTURER'S QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE FIRST AND THE SECOND FIRINGS WERE SUCCESSFUL. AT THE THIRD FIRING, THEY CONNECTED THE ADAPTER AND CHECKED THE JAWS OPENING/CLOSING. THEN THE SURGEON PUSHED THE GREEN FIRING MODE BUTTON AND PUSHED THE BLUE BUTTON, HOWEVER COULD NOT FIRE THE DEVICE. REPLACED BY A NEW CARTRIDGE, THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. THE STATUS OF THE PATIENT IS NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803918 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT N7F1092KX 30884523003219

    Patients

    Seq Age Sex Outcome Treatment
    1