BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA AUTO SUTURE UNIVERSAL STAPLER

    MDR report key: 3805754 · Received May 6, 2014

    Report

    Report Number
    MW5036009
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 27, 2014
    Manufacturer
    COVIDIEN LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COVIDIEN ENDO GIA AUTO SUTURE UNIVERSAL STAPLER WAS ATTEMPTED TO BE USED ON A (B)(6) YEAR OLD PATIENT IN A HOSPITAL OPERATING ROOM. THE PATIENT WAS HAVING SURGICAL PROCEDURE FOR ACUTE APPENDICITIS (LAPAROSCOPIC APPENDECTOMY). THE INSTRUMENT WAS DESCRIBED AS OPENED OUTSIDE THE PATIENT AND IT WOULD NOT CLOSE, SO THAT IT COULD BE PASSED THROUGH THE PORT. THE INSTRUMENT WAS RELOADED AND CLOSED, SO THAT IT COULD BE PASSED THROUGH THE PORT AND INTO THE PATIENT. THE INSTRUMENT WAS DESCRIBED AS NOT OPENING. ONCE THE HANDPIECE WAS REPLACED, THE INSTRUMENT WAS ABLE TO BE OPENED AND CLOSED WITHOUT INCIDENT. THE SURGEON DOCUMENTED THE INSTRUMENT WAS USED AS "THE APPENDIX WAS TRANSECTED WITH AN ENDO GIA STAPLER". THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL AND TAKEN TO THE RECOVERY ROOM WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271135 ENDO GIA AUTO SUTURE UNIVERSAL STAPLER ENDO GIA AUTO SUTURE UNIVERSAL STAPLER GDW COVIDIEN LLC 30449 N3L0888X

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization ZYRTEC 10MG PO DAILY