BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING XTRA THICK SULU

    MDR report key: 3964887 · Received July 17, 2014

    Report

    Report Number
    1219930-2014-00535
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K093410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LUNG BIOPSY. ACCORDING TO THE REPORTER: CUSTOMER INFORMS THAT THEY HAVE EXPERIENCED SOME ISSUES WITH THESE PRODUCTS DURING A THORACIC SURGERY. SAME EGIAUSNTD USED WITH ALL THE SULUS USED DURING THE PROCEDURE. THE CUSTOMER OPENED A EGIA60AXT AND OBSERVED THAT THE STAPLE LINE DID NOT HOLD. THE STAPLING LINE IN THE LUNG LOOKED AT THE FIRST CORRECT, BUT SOON IT BEGAN TO OPEN. THE SURGERY WAS LAPAROSCOPIC AND HAD TO BE CONVERTED TO AN OPEN SURGERY. IN ORDER TO SOLVE THE PROBLEM THEY SUTURED MANUALLY. IN ADDITION, SOME STAPLES FELL IN THE PATIENT CAVITY AND WERE RETRIEVED USING GRASPING PINCERS. TO FINISH THE SURGERY THEY DECIDED TO CHANGE THE EGIAUSTND HANDLE FOR A NEW ONE, WHICH WAS USED WITH TWO 030458 RELOADS, AND THE STAPLING WAS CORRECT AND NO FURTHER ISSUES WERE EXPERIENCED. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE. PATIENT STATUS WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420615 EGIA 60 ARTICULATING XTRA THICK SULU DISPOSABLE SURGICAL STAPLER GDW COVIDIEN LP, FORMERLY US SURGICAL N3H1326X

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention