BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 100-4.8 SINGLE USE RELOADABLE

    MDR report key: 3964908 · Received July 19, 2014

    Report

    Report Number
    2647580-2014-00441
    Event Type
    Injury
    Date Received
    July 19, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LUNG RESECTION. ACCORDING TO THE REPORTER: THE SURGEON FIRED ALL THE WAY DOWN AND PULLED BACK UP BUT WHEN HE OPENED THE GIA THE STAPLE LINE DID NOT HOLD AND THE TISSUE BURST OPEN. HE USED ANOTHER RELOAD AND IT DID THE SAME. PT SUFFERED BLOOD LOSS OF 1800 CCS THAT WAS NOT EXPECTED. NO OTHER INJURIES AND THE OUTCOME WAS GOOD. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE. THEY HAD TO SUTURE THE LUMEN CLOSED. TIME WAS EXTENDED BY MORE THAN 30 MINS BUT THERE WAS NO TISSUE LOSS OR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423988 GIA 100-4.8 SINGLE USE RELOADABLE DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P3L0290X

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other GIA 100-4.8 SINGLE USE LOADING UNIT MFG: 06/2011| GIA10048L LOT #: P1F0077 EXP: 06/30/2016