BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 494317 · Received November 7, 2003

    Report

    Report Number
    1219930-2003-00251
    Event Type
    Death
    Date Received
    November 7, 2003
    Date of Event
    October 13, 2003
    Report Date
    October 14, 2003
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WAS BROUGHT IN FOR A ROUTINE PNEUMONECTOMY (OPEN) SECONDARY TO ADENOCARCINOMA OF THE RIGHT LUNG, FOR WHICH PATIENT HAD RECEIVED RADIATION AND CHEMOTHERAPY FOR IN THE PAST. INSTRUMENTS WORKED FINE DURING THE PROCEDURE AND PATIENT HAD MINIMAL BLOOD LOSS DURING PROCEDURE. BROUGHT TO PACU AT 1654, AWAKE, ALERT, ORIENTED X3 AND PATIENT RETURNED TO OR AT 1730. PATIENT OPENED AND THEIR CHEST WAS FULL OF BLOOD, THE STAPLE LINES COULD NOT BE VISUALIZED. PATIENT EXPIRED IN THE OR. ADDITIONAL INFORMATION RECEIVED: PATIENT RECEIVED CXR IN OR AND NO FLUID/BLOOD WAS NOTED IN THE CHEST AT THAT TIME. PATIENT SENT TO PACU, WHERE THE NG TUBE WAS REPOSITIONED AND THE PATIENT COUGHED AND HAD A VALSALVA MANEUVER AND BP DROPPED. PATIENT RETURNED TO OR TO FIND APPROXIMATELY 4 LITERS OF BLOOD IN THE CHEST - 8 LITERS WERE REPLACED. SURGEONS LOOKED AT SPECIMEN IN PATHOLOGY AND PROPER STAPLE FORMATION WAS NOTED. GOOD HEMOSTASIS WAS NOTED AT TIME OF INITIAL SURGERY. THE CORONER REQUESTED NO AUTOPSY TO BE PERFORMED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GAG NORTH HAVEN - USS NA N3H258

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death 017614 - ROTICULATOR 55-4.8 EXP DATE: 5/2008.| 030454 - ENDO GIA ROTICULATOR SULU| LOT# P3D02.| LOT NUMBER UNK, EXP DATE UNK.