BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7146057 · Received December 26, 2017

    Report

    Report Number
    1219930-2017-10481
    Event Type
    Malfunction
    Date Received
    December 26, 2017
    Date of Event
    June 26, 2017
    Report Date
    December 26, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    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. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE RELOAD HAD A FULL STAPLE COMPLEMENT. FUNCTIONALLY, THE RELOAD WAS LOADED INTO PMV REPRESENTATIVE INSTRUMENTS AND APPLIED TO TEST MEDIA. ALL STAPLES WERE PLACED PROPERLY AND THE TEST MEDIA WAS CLEANLY TRANSECTED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. THIS EVENT WAS PREVIOUSLY REPORTED TO THE FDA ON A SUMMARY REPORT AND IS NOW BEING SUBMITTED ON A 3500A PER FDA REQUEST.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE SURGEON CLAMPED SIGMOID AND TRIED TO FIRE THE DEVICE, HOWEVER COULD NOT BE FIRED. THE STATUS OF THE EACH INDICATOR WAS NOT AVAILABLE. THE SURGEON REMOVED THE DEVICE FROM THE TISSUE, REPLACED BY AN ULTRA HANDLE AND THE PROCEDURE WAS COMPLETED. NO HARM WAS CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925497 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AVM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1