BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 4220587 · Received November 3, 2014

    Report

    Report Number
    1219930-2014-00992
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 20, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: WEDGE RESECTION. ACCORDING TO THE REPORTER: THORACO/WEDGE/SEGMENTAL USED WITH IDRIVE. IN THE MIDDLE OF FIRING IT STOPPED AND COULD NOT COMPLETE THE FIRING. SOME STAPLES WERE FIRED ON THE TISSUE. NEW ONE WAS OPENED TO COMPLETE THE INCOMPLETE STAPLE LINE WITH NO PROBLEM. NO PATIENT HARM. THE PATIENT CURRENT STATUS: GOOD. OPERATING TIME WAS NOT EXTENDED. NO TISSUE DAMAGE OR ADDITIONAL RESECTION NECESSARY. NO TISSUE DAMAGE. NOTHING FELL INTO THE CAVITY. NO BLEEDING. REPORTED NO PROBLEM IN RELEASE FROM TISSUE. NO INFO OF LOT NUMBER IS AVAILABLE. CONFIRMED THAT THE CLINICAL SAMPLE IS BEING RETURNED FOR INVESTIGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702686 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLER GAG COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA60AMT NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1