BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-4.8 SULU

    MDR report key: 2170071 · Received July 13, 2011

    Report

    Report Number
    2647580-2011-00462
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 2, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: WEDGE RESECTION. ACCORDING TO THE REPORTER: THE SLIP ON THE BOTTOM OF I-BEAM WAS FOUND BROKEN DURING THE SURGERY. THE SURGEON CHANGED TO ANOTHER DEVICE THAT HAD THE SAME PROBLEM. HE CHANGED A NEW GUN AND A THIRD DEVICE THAT ALSO HAD THE SAME PROBLEM. ONLY ONE SLIP OF I-BEAM WAS FOUND AND THE OTHER TWO BROKEN SLIPS WERE LEFT IN THE THORACIC CAVITY OF PATIENT, HAVING NOT BEEN FOUND. NO PATIENT INJURY WAS REPORTED. OPERATIVE TIME WAS EXTENDED BY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 60-4.8 SULU DISPOSABLE STAPLER GDW USSC PUERTO RICO P1A0520

    Patients

    Seq Age Sex Outcome Treatment
    1 Other