BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 90 - 3.5 SINGLE USE RELOADABLE STAPLER

    MDR report key: 4623914 · Received March 23, 2015

    Report

    Report Number
    2647580-2015-00227
    Event Type
    Injury
    Date Received
    March 23, 2015
    Date of Event
    February 23, 2015
    Report Date
    February 27, 2015
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: THERE WAS A BAD STAPLE LINE FORMATION (SURGEON BELIEVES THAT THE ALIGNMENT PIN WAS NOT WELL POSITIONED AND THIS COULD HAVE CAUSED THE MALFORMATION OF STAPLE LINE). USED ANOTHER TA9035S TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR ILL-EFFECTS. NO MEDICAL INTERVENTION REQUIRED. TISSUE LOSS: 2 CM. NO TISSUE DAMAGE OR BLEEDING. NO REINFORCEMENT MATERIAL USED. NO EXTENSION TO SURGICAL TIME REQUIRED. NOTHING FELL IN THE SURGICAL CAVITY. PATIENT CURRENT STATUS REPORTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193182 TA 90 - 3.5 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC TA9035S P0J0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other