BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYSTOSCOPE DEVICE 1

    MDR report key: 297688 · Received September 25, 2000

    Report

    Report Number
    297688
    Event Type
    Death
    Date Received
    September 25, 2000
    Date of Event
    September 6, 2000
    Report Date
    September 21, 2000
    Manufacturer
    OLYMPUS AMERICA
    Product Code
    KOG
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING PERCUTANEOUS NEPHROLITHOSTOMY, PT RECEIVED 42,000 CC STERILE WATER IRRIGANT INTO KIDNEY. POST PROCEDURE, PT DID NOT RESUME PRIOR LEVEL OF CONSCIOUSNESS. LAB WORK SHOWS HYPONATREMIA. CT SHOWS CEREBRAL EDEMA. AUTOSPY REVEALED MULTIPLE PUNCTURE WOUNDS OF KIDNEY WITH ZIG ZAG TRAUMA TO KIDNEY VASCULAR BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYSTOSCOPE DEVICE 1 FLEXIBLE CYSTOFIBERSCOPE KOG OLYMPUS AMERICA CYF-3 *
    10 CYSTOSCOPE CYSTOSCOPE --- CIRCON CORP. M2 *
    11 CYSTOSCOPE CYSTOSCOPE --- CIRCON CORP. G117 *
    12 CYSTOSCOPE CYSTOSCOPE --- CIRCON CORP. G121 *
    13 RENAL DILATOR SET DILATOR SET --- COOK UROLOGICAL * *
    2 NEPHROSCOPE NEPHROSCOPE FED OLYMPUS AMERICA A3336A *
    3 OBTURATOR OBTURATOR FBP OLYMPUS AMERICA A3337 - 3338 *
    4 GRABBER GRABBER, RETRIEVER FED OLYMPUS AMERICA A3333 *
    5 PROBE, LITHO LITHOTRIPSY PROBE DQX KARL STORZ 27080 GA UNK
    6 GUIDE WIRE GUIDE WIRE --- MICROVASIVE BOSTON SCIENTIFIC CORP. * UNK
    7 GUIDE WIRE GUIDE WIRE DQX MICROVASIVE BOSTON SCIENTIFIC CORP * UNK
    8 GUIDE WIRE GUIDE WIRE --- MICROVASIVE BOSTON SCIENTIFIC CORP * *
    9 EXTRACTOR/GRASPER EXTRACTOR --- MICROVASIVE BOSTON SCIENTIFIC CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death