BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGINEEDLE 150MM LONG INSTRUMENT

    MDR report key: 1701137 · Received May 19, 2010

    Report

    Report Number
    1219930-2010-00411
    Event Type
    Death
    Date Received
    May 19, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 23, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K863330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THIS INCIDENT WAS ALSO REPORTED BY THE ACCOUNT UNDER UF/IMPORTER REPORT# (B) (4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CYSTOSCOPY AND ATTEMPTED LAPAROSCOPIC/ROBOTIC PARTIAL NEPHRECTOMY. CYSTOSCOPY PORTION COMPLETED WITHOUT PROBLEMS. PT 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. PT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGINEEDLE 150MM LONG INSTRUMENT DISPOSABLE SURGICAL ACCESS DEVICE GCJ UNITED STATES SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death ETHICON ENDOPATH XCEL