BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICH SULU

    MDR report key: 2896031 · Received December 27, 2012

    Report

    Report Number
    1219930-2012-01013
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 29, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: ON THE NINTH DAY AFTER SURGERY, THE PATIENT'S CONDITION GOT WORSE. BEFORE THAT, THE PATIENT WAS DOING WELL, HAD STARTED EATING AND THE DRAIN HAD BEEN REMOVED. THE PATIENT GOT A CT SCAN THREE TIMES AFTER SURGERY AND THE RESULTS WERE AS FOLLOWS: FIRST TIME: NO PROBLEM, PERFECT STAPLE LINE WAS CONFIRMED; SECOND TIME: THE STAPLE LINE WAS SLIGHTLY DISPLACED; THIRD TIME: THE STAPLES DROPPED AND THE STAPLE LINE WAS NOT SEEN. SINCE A MAJOR LEAK OCCURRED, RE-OPERATION WAS PERFORMED. DURING RE-OPERATION, ALL STAPLES WHICH APPLIED ON THE BLIND-END OF THE JEJUNUM, THE STUMP OF DUODENUM AND THE ANASTOMOSED PART BETWEEN ESOPHAGUS AND JEJUNUM, WERE FOUND DROPPED. ALL OF THEM WERE B-SHAPED. THE MANUALLY SUTURED Y-PART HAD NO PROBLEM. THE STAPLES APPLIED ON THE ANASTOMOSED PART ALSO DROPPED, ALTHOUGH THREE QUARTERS OF THE TISSUE HAD ALREADY JOINED. THE SURGEON SUSPECTS THE PATIENT HAS AN ALLERGIC REACTION OR REJECTION OF TITANIUM AND THAT CAUSED INFLAMMATION OF TISSUE, RESULTING IN THE DROP OF STAPLES. HOWEVER, THE PATIENT HAS NEVER HAD A METALLIC ALLERGIC REACTION BEFORE. THE PATIENT IS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA 60 ARTICULATING MED/THICH SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other