BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 3638677 · Received February 12, 2014

    Report

    Report Number
    3638677
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 12, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PER SURGEON REQUEST, ENDO GIA UNIVERSAL X1 WAS TO BE OPENED AND REQUESTED WHITE 30, 2.5 MM RELOADS. SEVEN RELOADS TOTAL WERE USED. A SECOND REQUEST WAS MADE TO OPEN A SHORT ENDO GIA WITH 60, 2.5 MM RELOADS. TWELVE RELOADS TOTAL WERE USED. NOTICED THAT THE SCRUB TECH WAS HAVING ISSUES UNLOADING RELOADS FROM THE DEVICE. A THIRD ENDO GIA STANDARD WAS GIVEN TO THE SCRUB TECH TO ALLEVIATE DELAY. INFORMED SURGEON THAT WE WERE RUNNING OUT OF 60, 2.5 MM RELOADS AFTER LOOKING IN MULTIPLE AREAS. NURSE MANAGER ON DUTY CALLED TO HELP WITH SEAR. THEREFORE, TWO WHITE 45, 2.5 MM WERE GIVEN TO THE STERILE FIELD PER SURGEON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94267 ENDO GIA ULTRA STAPLER, SURGICAL GAG COVIDIEN * *
    94268 ENDO GIA ULTRA STAPLER, SURGICAL GAG COVIDIEN * *
    94269 ENDO GIA ULTRA STAPLER, SURGICAL GAG COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR