BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 2896065 · Received December 27, 2012

    Report

    Report Number
    1219930-2012-01022
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON (B)(4) 2012.

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: THE HANDLE WITH MAGAZINE FUNCTIONED PROPERLY. THEN THE COLON WAS FETCHED IN FRONT OF THE ABDOMINAL WALL WITH A SAVE CUT TO BEGIN PREPARATION AT THE DISTAL ILEUM. HERE THE SAME HANDLE WITH ANOTHER (B)(4) WAS USED. AFTER A PROPER FIRING OF THE MAGAZINE, THE DLU COULD NOT BE OPENED. THE SURGEON NOTICED THAT THE ANVIL HAD NOT BEEN PULLED BACK. THIS HAD OCCURRED MULTIPLE TIMES. A NEW HANDLE AND A FURTHER MAGAZINE WAS USED AND PLACED NEXT TO THE DEFECTIVE MAGAZINE AT THE TISSUE AND FIRED PROPERLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 030449, LOT #: N2G0238X, K061095,| EXP: 07/31/2017, MFG: 07/2012| ENDO GIA UNIVERSAL 12MM SINGLE USE INSTRUMENT,