BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA STAPLER

    MDR report key: 2941312 · Received January 25, 2013

    Report

    Report Number
    MW5028791
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    September 13, 2012
    Report Date
    January 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SURGERY APPENDECTOMY. AT END OF SURGERY STAPLE LINE INTACT. PT DEVELOPED BLEEDING, RETURNED TO SURGERY (B)(6) 2012. MD CONCERNED THERE MAY BE A PROBLEM WITH THE ENDO GIA STAPLER. THE ANASTOMOTIC SUTURE LINE HAD COME APART. PT DID WELL FOLLOWING PROCEDURE AND WAS DISCHARGED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36347 ENDO GIA STAPLER NONE GDW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR