BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 4170160 · Received October 14, 2014

    Report

    Report Number
    1219930-2014-00945
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAG
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION ACCORDING TO THE REPORTER: LAPAROSCOPIC LAR USED WITH IDRIVE, S/N: NOT AVAILABLE, A DOCTOR FOUND IT COULD NOT BE ARTICULATED. HOWEVER, CONTINUED USE. AFTER GRASPING THE TISSUE WITH USE OF THIS ONE, IT COULD NOT FIRE AT ALL. A DOCTOR CONFIRMED THE BLUE STATUS INDICATOR LAMP WAS LIT UP ON THE DEVICE AND THE GREEN CARTRIDGE STATUS INDICATOR LAMP WAS LIGHTING. NEW ONE WAS OPENED TO COMPLETE THE CASE WITH NO PROBLEM. IT WAS NOT USED ON PATIENT. NO PATIENT INVOLVEMENT. NO TISSUE DAMAGE, NO TISSUE LOSS, NO BLEEDING. NO ANTICIPATED TISSUE LOSS. NOTHING OF ADVERSE EVENT CAUSED BY EXTENSION OF OR TIME WAS REPORTED. THE PATIENT CURRENT STATUS: GOOD ONLY THE INVESTIGATIONS OF THE SULU WAS REQUIRED BY THE CUSTOMER. THE PATIENT CURRENT STATUS: GOOD AFTER PROCEDURE WHEN IDRIVE WAS RESTARTED NO PROBLEM WAS CONFIRMED. REPORTED NO PROBLEM IN RELEASE FROM TISSUE. OPERATING TIME EXTENDED: LESS THAN 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649898 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLER GAG COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA60AMT

    Patients

    Seq Age Sex Outcome Treatment
    1 IDRVULTRA1, IDRIVE ULTRA POWERED HANDLE 1, K121510