BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7078158 · Received December 3, 2017

    Report

    Report Number
    1219930-2017-09263
    Event Type
    Malfunction
    Date Received
    December 3, 2017
    Date of Event
    April 10, 2017
    Report Date
    December 3, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS PREVIOUSLY REPORTED TO THE FDA ON A SUMMARY REPORT AND IS NOW BEING SUBMITTED ON A 3500A PER FDA REQUEST. 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 AN ESOPHAGECTOMY / GASTRIC TUBE PROCEDURE. THE STAPLING DEVICE WAS BEING USED FOR THE GASTRIC TUBE RECONSTRUCTION. FOR THE EIGHT FIRING THE SURGEON TIRED TO FIRE THE DEVICE, HOWEVER, COULD NOT. THEY RECOGNIZED THAT THE CARTRIDGE WAS PRE-FIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857220 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1