BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 8649750 · Received May 29, 2019

    Report

    Report Number
    1219930-2019-03141
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    May 3, 2019
    Report Date
    July 31, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003215
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 WAS PRE-FIRED AND ENGAGED IN INTERLOCK. THERE WERE STAPLES PROTRUDING FROM PROXIMAL STAPLE CARTRIDGE CHANNEL. FUNCTIONALLY THE RELOAD WAS LOADED INTO A POST MARKET VIGILANCE INSTRUMENT, THE INTERLOCK WAS OVERRIDDEN, AND THE RELOAD 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 QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE PRE-FIRE CONDITION WITH INTERLOCK ENGAGEMENT MAY OCCUR IF THE INSTRUMENT FIRING HANDLE HAD BEEN PARTIALLY COMPRESSED AND RELEASED AFTER PRESSING THE GREEN FIRING BUTTON. IN THIS SITUATION, THE SAFETY INTERLOCK FEATURE WILL ENGAGE AND PREVENT THE RELOAD FROM FIRING A SECOND TIME BY CEASING THE PLACEMENT OF STAPLES AND TISSUE TRANSECTION AND PREVENT PATIENT HARM. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS DUE TO THE PRODUCT NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. 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 PROCEDURE, WHEN TRYING TO FIRE THE DEVICE, THE HANDLE WAS STIFF AND COULD NOT BE SQUEEZED. THE RELOAD WAS REPLACED WITH A NEW ONE AND IT WAS USED WITHOUT PROBLEM. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445012 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT N9B0042KY 10884523003215

    Patients

    Seq Age Sex Outcome Treatment
    1