BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 4861529 · Received June 23, 2015

    Report

    Report Number
    1219930-2015-00490
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 26, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PROXIMAL PANCREATICODUODENECTOMY. CUSTOMER STATES: PRIOR TO THE SECOND FIRING, EGIA60AMT WAS LOADED BY I-DRIVE, BUT IT WOULD NOT BE FIRED WHEN CUTTING OFF STOMACH 3CM FROM PYLORUS RING. THE PRODUCT WAS DISCARDED BY OUR CUSTOMER. NO PATIENT HARM. OPERATING TIME EXTENDED: LESS THAN 30 MIN. TISSUE DAMAGE: NO. NOTHING FELL INTO THE CAVITY. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405586 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA60AMT

    Patients

    Seq Age Sex Outcome Treatment
    1