BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 45 ARTICULATING XTRA THICK SULU

    MDR report key: 4810556 · Received June 2, 2015

    Report

    Report Number
    1219930-2015-00437
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 5, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAG
    PMA / PMN Number
    K093410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TOTAL MESORECTAL EXCISION (TME) ACCORDING TO THE REPORTER: DR. (B)(6) PERFORMED THE ROBOTIC TME WITH THE USE OF EGIA45AXT AND IDRIVE ULTRA HANDLE. BEFORE THE APPLICATION, THE SCRUB NURSE CARRIED OUT THE TESTING WITH IDRIVE. WHEN THE SCRUB NURSE INSERTED THE EGIA45AXT TO THE IDRIVE, THEY FOUND THAT THE GREEN LOADING INDICATOR LIGHT KEPT BLINKING EVEN THEY HAD PERFORMED THE OPEN AND CLOSE JAW PROCEDURES. DR. (B)(6) SUSPECTED THE RELOAD WITH PROBLEM AND DECIDED NOT TO APPLY ON PATIENT. THEY FIRED THE LOADING OUTSIDE THE PATIENT AND THAT THE LOADING HEAD KEPT MOVING DURING THE FIRING. AND THEY OPENED A NEW EGIA45AXT AND LOADED IT TO THE SAME IDRIVE HANDLE, NO PROBLEM WAS DETECTED AND COULD SUCCESSFULLY APPLY ON PATIENT. DR. (B)(6) CONCLUDED THE PROBLEM CAME FROM THE FIRST RELOAD BUT NOT FROM IDRIVE, THEY RETURNED THE RELOAD FOR INVESTIGATION. HOW WAS IT DETECTED: PREPARATION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357115 EGIA 45 ARTICULATING XTRA THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA45AXT N4K1493KX

    Patients

    Seq Age Sex Outcome Treatment
    1