BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EEA

    MDR report key: 1240474 · Received November 20, 2008

    Report

    Report Number
    2647580-2008-00648
    Event Type
    Death
    Date Received
    November 20, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GAG
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 11/20/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: A TA STAPLER WAS CLOSED AND SQUEEZED TWICE OVER THE DISTAL COLON. WHEN THE INSTRUMENT WAS OPENED THERE WERE NO STAPLES SEEN ACROSS THE RECTAL STUMP. ANOTHER TA WAS USED AND A DISTAL STAPLE LINE WAS OBSERVED. AN EEA WAS THEN USED TO PERFORM AN ANASTOMOSIS OF THE BOWEL. THE DONUTS WERE OBSERVED TO BE POOR. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATION. TWO DAYS POST-OPERATIVELY, THE PT WAS RETURNED TO THE OR BECAUSE OF REPORTED LEAKING. THE LEAK WAS REPAIRED, HOWEVER, THE PT EXPIRED THREE DAYS LATER. THE PT HAD CANCER, BUT NO RADIATION THERAPY WAS GIVEN PRIOR TO THE SURGERY. NO AUTOPSY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN EEA DISPOSABLE SURGICAL STAPLER GAG PONCE-USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death PRODUCT ID: TA4535S| TA 45-3.5 SINGLE USE RELOADABLE STAPLER