BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-3.5 SULU

    MDR report key: 1971440 · Received January 18, 2011

    Report

    Report Number
    1219930-2011-00034
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON (B)(4) 2011.

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: NORMAL OPERATION UNTIL RESECTION OF RECTUM. TWO ARTICULATING BLUE RELOADS 45 WERE USED TO RESECT THE RECTUM, AND AFTER THAT ONLY A SMALL PART OF RECTUM WAS LEFT. A NEW SIMILAR RELOAD WAS USED FOR THE LAST SMALL PART. THEN A SIGNIFICANT BLEEDING WAS SEEN FROM THE "TOP" OF THE RECTUM. AFTER A CLOSE INSPECTION THEY DISCOVERED A HOLE IN THE CORNER THAT SHOULD HAVE BEEN CLOSED WITH THE RELOAD. AWAY FROM THIS THEY HAD ONLY INSIGNIFICANT AMOUNT OF BLEEDING. BECAUSE OF THIS THEY HAD TO CONVERT TO LAPAROTOMY. THE END OF THE PROXIMAL RECTUM WAS CLOSED AS IT SHOULD. THE PT SEEMS FINE EXCEPT FROM COSMESIS DUE TO THE LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-3.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0C0764

    Patients

    Seq Age Sex Outcome Treatment
    1