BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH XCEL

    MDR report key: 1664731 · Received April 20, 2010

    Report

    Report Number
    1664731
    Event Type
    Death
    Date Received
    April 20, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 20, 2010
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD CYSTOSCOPY AND ATTEMPTED LAPAROSCOPIC/ROBOTIC PARTIAL NEPHRECTOMY. CYSTOSCOPY PORTION COMPLETED WITHOUT PROBLEMS. PATIENT TURNED TO LEFT SIDE AND SURGEON INSERTED VERESS NEEDLE WITH INTENTION OF INJECTING CO2 INTO CAVITY, BUT WAS NOT CERTAIN HE WAS IN CORRECT PLACE. REMOVED VERESS NEEDLE. INSERTED OPTIVIEW TROCAR INTO RIGHT FLANK, BUT AGAIN NOT CERTAIN OF CORRECT POSITION; SAW FAT TISSUE, PULLED BACK AND ADVANCED AGAIN, SOME BLEEDING WAS NOTED. ANESTHESIA REPORTED SIGNIFICANT DROP IN BLOOD PRESSURE. PATIENT PLACED SUPINE, CPR STARTED, ABDOMEN OPENED, BRISK HEMORRHAGE RIGHT LOWER QUADRANT. ABDOMEN PACKED, AORTA CLAMPED. RESUSCITATIVE EFFORTS INCLUDING BLOOD TRANSFUSION. PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL SURGICAL TROCAR GCJ ETHICON ENDO-SURGERY * *
    2 SURGINEEDLE PNEUMOPERITONEUM NEEDLE HIF COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death