BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA STAPLER

    MDR report key: 823611 · Received February 20, 2007

    Report

    Report Number
    823611
    Event Type
    Injury
    Date Received
    February 20, 2007
    Date of Event
    December 1, 2006
    Report Date
    February 20, 2007
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT UNDERWENT SUBTOTAL COLECTOMY FOR GI BLEED. EEA STAPLER WAS USED FOR THE ANASTOMOSIS. BLOOD SUPPLY WAS ADEQUATE AND NO LEAKS WERE NOTED WHEN CHECKED. HIS CONDITION IMPROVED AND HE WAS DISCHARGED HOME. PATIENT RETURNED TO THE OR NINE DAYS POST-OP. HE WAS READMITTED FOR EXPLORATORY LAPAROTOMY, WHICH REVEALED STAPLE LINE DEHISCENCE. SURGEON WAS CONCERNED ABOUT USING AN EEA STAPLER AGAIN DUE TO THE PREVIOUS FAILURE OF THE ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA STAPLER STAPLER, SURGICAL GAG UNITED STATES SURGICAL CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R NO OTHER THERAPIES