BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 7847505 · Received September 5, 2018

    Report

    Report Number
    2647580-2018-04417
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    September 5, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: THE ANESTHETIC CHALLENGES OF LUNG BIOPSY ¿ ASSOCIATED INTRATHORACIC HEMORRHAGE IN A CHILD WITH SUPRASYSTEMIC PULMONARY HYPERTENSION SOURCE SEMINARS IN CARDIOTHORACIC AND VASCULAR ANESTHESIA (172¿ 177) 2017, ARTICLE NUMBER: 21(2). (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A PREVIOUSLY HEALTHY (B)(6) YEAR OLD GIRL, NEWLY DIAGNOSED WITH SUPRASYSTEMIC PULMONARY HYPERTENSION REQUIRED MULTIPLE LUNG BIOPSIES. ACUTE HEMORRHAGE FROM THE LATERAL PORTION OF THE STAPLE LINE WAS IDENTIFIED AND CONTROLLED WITH TWO CLIP APPLIERS. AN ADDITIONAL 400 ML OF BLOOD WAS EVACUATED FROM THE LEFT CHEST. SIGNIFICANT BLEEDING ENSUED FROM THE STAPLE LINE OF THE BIOPSY SITE AND A VASCULAR STAPLE LOAD WAS DEPLOYED IN ORDER TO CONTROL THE HEMORRHAGE. BLOOD LOSS WAS ESTIMATED AT 200 ML. AFTER AN OPEN LUNG BIOPSY USING THE STAPLER FOR HEMOSTASIS THE PATIENT BECAME INCREASINGLY HYPOTENSIVE AND THE CHEST TUBE DRAINAGE INCREASED. THE DECISION WAS MADE TO REOPEN THE CHEST, AND BLEEDING FROM THE LUNG BIOPSY SITE WAS APPRECIATED. BOTH INSTANCES REQUIRED REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685988 ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN ENDO GIA INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention