BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA ULTRA

    MDR report key: 14618303 · Received June 7, 2022

    Report

    Report Number
    14618303
    Event Type
    Death
    Date Received
    June 7, 2022
    Date of Event
    May 26, 2022
    Report Date
    June 3, 2022
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SCHEDULED DONOR LAPAROSCOPIC NEPHRECTOMY PROCEDURE. THE PATIENT WAS PLACED ON THE OPERATING ROOM TABLE IN RIGHT DECUBITUS POSITION AND HER ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE SURGEON FIRST MADE 5 CM LONG PFANNENSTIEL INCISION TO ENTER ABDOMINAL CAVITY. LAP HAND PORT WAS INSTALLED TO THIS INCISION AND PNEUMOPERITONEUM WAS CREATED. UNDER DIRECT VISION, THE SURGEON INSERTED TWO 12 MM LAP PORTS IN THE NAVEL AND LEFT ABDOMEN. ONE 5 MM PORT WAS ALSO INSERTED IN UPPER ABDOMEN ON THE MIDLINE. THE SURGEON STARTED THE PROCEDURE BY MOBILIZING LEFT COLON MEDIALLY. LEFT KIDNEY WAS IDENTIFIED AND MOBILIZED FROM THE UPPER POLE TO THE LOWER POLE. NEXT, THE URETER WAS IDENTIFIED AND WAS FREED UP TO THE PELVIC SPACE. THE SURGEON CONTINUED DISSECTION TO THE HILUM OF THE KIDNEY AND RENAL VEIN AND ADRENAL VEIN WERE IDENTIFIED. THE ADRENAL VEIN WAS TRANSECTED BY LIGASURE. THE SURGEON CONTINUED DISSECTION BETWEEN ADRENAL GRAND AND HILUM OF THE KIDNEY AND IDENTIFIED RENAL ARTERY. THE RENAL ARTERY WAS THEN DISSECTED TOWARDS THE AORTA. ANY CONNECTIVE TISSUE BETWEEN RENAL ARTERY AND RENAL VEIN WAS CAREFULLY TRANSECTED. THE SURGEON THEN FINALLY DISSECTED THE BACK OF RENAL VEIN AND GONADAL VEINS WAS TRANSECTED BY THE LIGASURE. THE SURGEON TRANSECTED THE URETER WITH GIA STAPLER. NEXT RENAL ARTERY WAS TRANSECTED WITH GIA. HOWEVER, WHEN THE STAPLER WAS PASSED TO THE RENAL VEIN THE SURGEON ENCOUNTERED MASSIVE BLEEDING. THE RENAL VEIN WAS STAPLED, AND THE KIDNEY WAS REMOVED QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141109 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW COVIDIEN LP EGIAUSTND

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Female Death