BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1993496 · Received February 8, 2011

    Report

    Report Number
    2647580-2011-00079
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 12, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLON RESECTION/RIGHT COLON. ACCORDING TO THE REPORTER: A LEAK THROUGH THE GIA STAPLE LINE WAS FOUND FOUR DAY POST-OP (ANASTOMOTIC LEAK). PT REQUIRED ANOTHER SURGERY TO CORRECT LEAK. THE ORIGINAL SURGERY WAS RIGHT COLON RESECTION TO REMOVE A TUMOR. NO ISSUES ON THE ORIGINAL SURGERY. RE-OPERATION TOOK PLACE ON (B)(6) 2011, THE STAPLE LINE WAS INTACT, HOWEVER, THERE WAS A SMALL LEAK AT THE ANASTOMOTIC STAPLE LINE. PT RECOVERED AFTER SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention