BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 6479986 · Received April 11, 2017

    Report

    Report Number
    1219930-2017-05266
    Event Type
    Injury
    Date Received
    April 11, 2017
    Date of Event
    March 17, 2017
    Report Date
    July 11, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    30884523003219
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO PHOTOS OF THE STAPLE LINE MADE BY AN DEVICE. THE EVENT REPORT ALLEGES THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. THE VISUAL INSPECTION OF THE PHOTOS NOTED IRREGULAR STAPLE FORMATION. PMV FUNCTIONAL TESTING COULD NOT BE DONE DUE TO THE LACK OF PHYSICAL PRODUCT. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE ROOT CAUSE COULD NOT BE DETERMINED. NO RELATIONSHIP BETWEEN THE DEVICE FAILURE AND THE REPORTED INCIDENT WAS CONFIRMED. 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 LAP GASTRIC BYPASS PROCEDURE, THERE WAS POOR STAPLE FORMATION AND A PROXIMAL AND DISTAL INCOMPLETE STAPLE LINE. AN ETHICON STAPLER WAS USED TO FIX THE STAPLE LINE. NO REINFORCEMENT MATERIAL WAS USED. THERE WAS UNANTICIPATED TISSUE LOSS AND DAMAGE. MEDICAL INTERVENTION WAS REQUIRED BECAUSE THEY HAD TO TRANSECT AND STAPLE AROUND THE DEFECTIVE STAPLE LINE. THEY REMOVED ABOUT 2CM OF THE FUNDUS. THE DAMAGE WAS NOT PERMANENT. THERE WAS NO BLOOD LOSS OR EXTENSION OF SURGICAL TIME. PATIENT IS ALIVE WITH NO INJURY. THE PATIENT'S MEDICAL HISTORY IS OBESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263805 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT N7A0645KX 30884523003219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R