BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 60-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1133390 · Received August 22, 2008

    Report

    Report Number
    2647580-2008-00487
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 08/22/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: THIS WAS A MULTIPLE RESECTION CASE. DURING THE FOURTH FIRING (THIRD RELOAD), THE INSTRUMENT WAS FIRED TO CREATE THE ANASTOMOSIS, HOWEVER, THE STAPLER CUT BUT DID NOT DEPLOY ANY STAPLES. THREE EXTRA FIRINGS WERE NEEDED TO CORRECT THIS PROBLEM, AND ABOUT 4CM OF BOWEL WAS LOST ON EACH THE DISTAL AND PROXIMAL ENDS BECAUSE OF THIS. SOME BOWEL LEAKAGE OCCURRED, BUT NO BLEEDING OCCURRED. THERE WAS A 20 MINUTE DELAY IN OR TIME BECAUSE OF THE ISSUE. IT WAS ALSO NOTICED THAT THE WHITE TAB THAT COVERS THE KNIFE BLADE DID NOT ENGAGE AFTER THIS FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 60-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P8D0346

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT # P8A0681 AND P8C0831| GIA 60-3.8 SINGLE USE LOADING UNIT| CATALOG # GIA6038L