BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIA 60-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3834402 · Received May 19, 2014

    Report

    Report Number
    2647580-2014-00365
    Event Type
    Death
    Date Received
    May 19, 2014
    Date of Event
    January 15, 2014
    Report Date
    April 30, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CYSTECTOMY. ACCORDING TO THE REPORTER: CUSTOMER INFORMS THAT WHEN THEY HAVE PERFORMED THE LATERO-LATERAL ANASTOMOSIS IT HAS CREATED A FISTULA. THE PATIENT WAS INJURED. THERE WAS NO EXTENSION OF THE SURGERY TIME BY MORE THAN 30 MINUTES. IT WAS NECESSARY TO RE-OPERATE. THE PATIENT EXPIRED DUE TO SECONDARY COMPLICATIONS BECAUSE OF THE DIGESTIVE FISTULA. THIS INFORMATION IS BASED ON THE CALL FROM THE SALES REP AND HE HIMSELF HAS BEEN INFORMED ON (B)(6) 2014 BY THE DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295775 GIA 60-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death