BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN

    MDR report key: 4105997 · Received September 3, 2014

    Report

    Report Number
    4105997
    Event Type
    Death
    Date Received
    September 3, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 29, 2014
    Manufacturer
    COVIDIEN LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT, A (B)(6) YEAR-OLD FEMALE, WITH A MEDICAL HISTORY OF RIGHT SIDED LUNG CANCER UNDERWENT A RIGHT PNEUMONECTOMY ON (B)(6) 2014. AS THE SURGEON WAS STAPLING THE INFERIOR PULMONARY VEIN THE COVIDIEN STAPLER PRODUCED WHAT HAS BEEN DESCRIBED AS A "CRACKLING SOUND". THE STAPLES FIRED AND THE CASE PROCEEDED. WHEN THE SURGEON WAS WORKING ON THE BRONCHUS THE SAME STAPLER WAS UTILIZED, WITH A DIFFERENT STAPLE LOAD. THE STAPLER FAILED TO DEPLOY THE STAPLES. A NEW STAPLE LOAD WAS INSTALLED AND AGAIN THE STAPLER FAILED TO DEPLOY THE STAPLERS. A NEW STAPLER WAS INTRODUCED AND SUCCESSFULLY DEPLOYED THE STAPLE LOAD. THE RIGHT LUNG WAS RESECTED WITHOUT APPARENT COMPLICATION. THE PT WAS EXTUBATED AND TOOK BREATHS ON COMMAND. SHORTLY THEREAFTER, WHILE STILL IN THE OPERATING ROOM, ANESTHESIA NOTICED THAT THE PATIENT HAD BECOME PULSELESS. ACLS PROTOCOL WAS IMMEDIATELY INITIATED. THE SURGICAL INCISION WAS REOPENED AND A LARGE VOLUME OF BRIGHT RED BLOOD WAS NOTED IN THE CHEST CAVITY. DESPITE FULL RESUSCITATIVE EFFORTS, INCLUDING MASS TRANSFUSION AND HEART MASSAGE, THE PATIENT EXPIRED. THE SURGEON NOTED THAT THE INFERIOR PULMONARY VEIN STAPLE LINE HAD DEHISCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535757 COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER, EGIAUSHORT GDW COVIDIEN LLC. EGIAUSHORT P4A0172X

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death