BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1790130 · Received August 2, 2010

    Report

    Report Number
    2647580-2010-00671
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 15, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BILE DUCT REPAIR. ACCORDING TO THE REPORTER: THE SURGEON SAID THAT THE STAPLER CUT TISSUE BUT DID NOT STAPLE. HE FIRED ACROSS JEJUNUM THAT HE DESCRIBED AS NORMAL. THE FIRST FIRING STAPLED AND CUT. THE SECOND RELOAD WAS INSERTED AND HE FIRED THE INSTRUMENT AND IT CUT THE TISSUE BUT DID NOT LAY STAPLES. THE SCRUB TECH WHO SAID THAT BLACK METAL BARS CAME OUT OF THE STAPLER AFTER THE FIRST FIRING. HE THOUGHT THEY WERE PART OF THE RELOAD. WE EXAMINED THE FIRST AND SECOND RELOADS USED: THE YELLOW PUSHER BARS WERE VISIBLE ON THE FIRST RELOAD BUT NOT ON THE SECOND RELOAD. THE STAPLER, 2 RELOADS AND BLACK METAL BARS WERE COLLECTED AND ARE IN THE POSSESSION OF RISK MANAGEMENT AT THE HOSPITAL. THE SURGEON HAND-SEWED THE CUT LINE. THERE WAS SOME ADDITIONAL BLEEDING BUT UNDER 250CC. THE OPERATIVE TIME WAS EXTENDED MORE THAN 30 MINUTES. NO PATIENT INJURY WAS REPORTED. PATIENT STATUS IS OK.

    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 P0E0141

    Patients

    Seq Age Sex Outcome Treatment
    1 GIA 80-3.8 SINGLE USE LOADING UNIT (GIA8038L)| LOT# P9M0160, 510K# K013860