BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREMIUM MF TA 90-3.5 TITANIUM STAPLER

    MDR report key: 377343 · Received February 15, 2002

    Report

    Report Number
    1219930-2002-00010
    Event Type
    Death
    Date Received
    February 15, 2002
    Date of Event
    December 6, 2001
    Report Date
    January 18, 2002
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, AN END TO END ANASTOMOSIS WAS ESTABLISHED DURING AN OPERATION FOR CANCER IN THE RECTUM. SHORTLY AFTER THE END OF THE OPERATION, THE PT EXPERIENCE A LEAKAGE OF THE ANASTOMOSIS AND IS SUBJECTED TO RESURGERY. DURING RESURGERY, THE SURGEON FINDS THE ORIGINAL STAPLES COMPLETELY UNBENT. THE PT EXPIRED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM MF TA 90-3.5 TITANIUM STAPLER DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death