BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60- 4.8 SULU

    MDR report key: 1022009 · Received March 31, 2008

    Report

    Report Number
    1219930-2008-00252
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 7, 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: LUNG RESECTION. ACCORDING TO THE REPORTER: FIRST FIRING WAS SUCCESSFUL BUT ON SECOND FIRING, HANDLE LOCKED UP. INSTRUMENT WAS ABLE TO BE REMOVED WITH NO TISSUE DAMAGE. RE-FIRED WITH NEW STAPLER AND CARTRIDGES A COUPLE TIMES BUT SAME THING OCCURRED. SURGEON TRIED FROM THE OTHER SIDE BUT STILL UNABLE TO FIRE. INCISION WAS EXTENDED A LITTLE AND FIRING WAS COMPLETED WITH TA45-4.8. THE ACCOUNT RETURNED 7 CARTRIDGES FROM FOUR DIFFERENT LOTS. HOWEVER, UNK WHICH OF THEM ARE DEFECTIVE AND ON WHICH FIRING THEY WERE USED. STAPLE LINE REINFORCEMENT WAS USED. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60- 4.8 SULU SURGICAL STAPLING DEVICE GAG NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK