BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 1023292 · Received April 1, 2008

    Report

    Report Number
    1219930-2008-00262
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 12, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: VATS LUNG BIOPSY. UNDER 200CC BLEEDING OCCURRED WHEN FIRED OVER RIGHT UPPER LOBE. THEY FOUND THE DISTAL STAPLES DID NOT FORM AT ALL. THE SECOND FIRING WAS SUCCESSFUL. THE INCISION WAS EXTENDED ABOUT 3CM TO SUTURE THAT INCOMPLETE STAPLE LINE MANUALLY. THE PATIENT WAS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL SURGICAL STAPLING DEVICE GAG NORTH HAVEN - USS N7M06

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ENDO GIA ROTICULATOR 60-3.5 SULU| EXPIRATION DATE: 11/30/2012| 030458| LOT N7L177