BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE DISP TA LONG 9048 TIT STAPLER

    MDR report key: 302052 · Received October 19, 2000

    Report

    Report Number
    2647580-2000-00816
    Event Type
    Malfunction
    Date Received
    October 19, 2000
    Report Date
    September 18, 2000
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, WHEN THE FINAL PORTION OF THE LUNG WAS AMPUTATED, IT BECAME EVIDENT THAT THE STAPLES WERE NOT HEMOSTATIC AND THERE WAS A SIGNIFICANT AMOUNT OF BLEEDING FROM THE PULMONARY ARTERY. THIS WAS QUICKLY CONTROLLED WITH PROLEEN SUTURES. THIS INFORMATION WAS OBTAINED BY A MEDWATCH RECEIVED IN Q/A IN 2000. RN CALLED IN 2000, AND MENTIONED THAT THEY DO NOT HAVE THE INSTRUMENT TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE DISP TA LONG 9048 TIT STAPLER DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORPORATION NA P7J206

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN