BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 45-4.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1944450 · Received December 28, 2010

    Report

    Report Number
    2647580-2010-01006
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAW ANTERIOR RESECTION/DOUBLE STAPLING. ACCORDING TO THE REPORTER: AFTER STAPLING WAS DONE, IT WAS NOTICED THAT THE STAPLE LINE WAS NOT COMPLETE. ADDITIONAL RESECTION AND RE-ANASTOMOSIS WAS DONE. NO BLEEDING. NOTHING FELL INTO THE PT'S CAVITY. EXTENDED MORE THAN 30 MINUTES. NO PT INFO AVAILABLE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 45-4.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P0H0543

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S