BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARYLAND JAW OPEN (23CM)

    MDR report key: 6356756 · Received February 24, 2017

    Report

    Report Number
    1717344-2017-00144
    Event Type
    Death
    Date Received
    February 24, 2017
    Date of Event
    January 13, 2017
    Report Date
    January 31, 2017
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    PMA / PMN Number
    K141153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THREE DAYS POST PROCEDURE BLEEDING OCCURRED ON THE A7 VESSEL THAT WAS SEALED BY THE DEVICE. A SECOND OPEN SURGERY WAS PERFORMED TO TREAT THE ISSUE. AS OVER 500CC'S OF BLOOD LOSS OCCURRED A TRANSFUSION WAS REQUIRED. THE PATIENT HAS EXPIRED ON (B)(6) 2017. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES THERE WAS NO EVENT AT THE FIRST OPERATION. THE PATIENT WAS AN (B)(6) MALE AND THE PROCEDURE WAS FOR LUNG CANCER. DURING THE 2ND PROCEDURE THERE WAS MORE THAN 5000CC OF BLOOD LOSS AND HE HAD 3600CC OR 18 UNITS TRANSFUSED DURING THE SECOND OPERATION AND POSTOPERATIVELY HAD MORE. THERE WILL BE NO AUTOPSY. THE CAUSE OF DEATH HAS BEEN ATTRIBUTED TO SHOCK AFTER MASSIVE BLOOD LOSS. THE SHOCK CAUSED RESPIRATORY FAILURE (MECHANICAL VENTILATION - BRONCHIAL FISTULA) AND DIC. ALTHOUGH THE SURGEON WAS NOT SURE THAT THERE WAS A DEHISCENCE OF SEALING, THE BLEEDING POINT WAS AROUND THE SEALING, NOT AT THE ROOT OF A7 VESSEL. THE BLEEDING HAPPENED JUST AFTER THE REMOVAL OF THE CHEST DRAINAGE TUBE. THE POSSIBLE CAUSES OF BLEEDING WERE A DEHISCENCE OF SEALING OR AN INJURY FROM DRAINAGE TUBE AT THE TIME OF REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139933 MARYLAND JAW OPEN (23CM) LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF1723

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death