BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7067677 · Received November 29, 2017

    Report

    Report Number
    1219930-2017-09093
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    March 31, 2017
    Report Date
    November 29, 2017
    Manufacturer
    COVIDIEN NORTH HAVEN-MFG
    Product Code
    GDW
    UDI-DI
    10884523003154
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE RELOAD. VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE RELOAD WAS PARTIALLY FIRED. MICROSCOPIC EVALUATION NOTED THAT THE RELOAD HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE. FUNCTIONALLY THE RELOAD WAS LOADED INTO A PMV INSTRUMENT, THE INTERLOCK WAS OVERRIDDEN, AND THE RELOAD WAS APPLIED TO TEST MEDIA. ALL REMAINING STAPLES WERE PLACED AND 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. REPLICATION OF THE DAMAGED KNIFE BLADE MAY OCCUR WHEN AN OBSTACLE HAS BEEN INCORPORATED IN THE JAWS DURING APPLICATION. THE INFORMATION BOOKLET WHICH ACCOMPANIES EACH PRODUCT SHIPMENT CAUTIONS THE USER; ENSURE THAT NO OBSTRUCTIONS (SUCH AS CLIPS) ARE INCORPORATED IN THE INSTRUMENT JAWS. FIRING OVER AN OBSTRUCTION MAY RESULT IN INCOMPLETE CUTTING ACTION AND/OR IMPROPERLY FORMED STAPLES. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY. DURING THE JEJUNOJEJUNOSTOMY, THE RELOAD PARTIALLY FIRED. THE STAPLE LINE WAS FORMED INCOMPLETELY AT THE DISTAL END. TO CORRECT THE INCOMPLETE STAPLE LINE, ANOTHER RELOAD WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847343 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN NORTH HAVEN-MFG EGIA45AMT N6B0232KX 10884523003154

    Patients

    Seq Age Sex Outcome Treatment
    1