BEUDAMED
    FDA Adverse Event Death Summary report: N

    STONE RETRIEVAL GRASPING FORCEPS/EXTRA STR/HOOK

    MDR report key: 303203 · Received November 3, 2000

    Report

    Report Number
    6000043-2000-00030
    Event Type
    Death
    Date Received
    November 3, 2000
    Date of Event
    September 6, 2000
    Report Date
    October 5, 2000
    Manufacturer
    MICROVASIVE UROLOGY / A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING PERCUTANEOUS NEPHROLITHOSTOMY, PT RECEIVED 42,000CC STERILE WATER IRRIGANT INTO KIDNEY. POST PROCEDURE, PT DID NOT RESUME PRIOR LEVEL OF CONSCIOUSNESS. LAB WORK SHOWS HYPONATREMIA. CT SHOWS CEREBRAL EDEMA. AUTOPSY REVEALED MULTIPLE PUNCTURE WOUNDS OF KIDNEY WITH ZIG-ZAG TRAUMA TO KIDNEY VASCULAR BED." THE HOSP STAFF DOES NOT THINK IT WAS THE FAULT OF THE DEVICE - MORE THE DIFFICULTY OF THE CASE AND POSSIBLE USER TECHNIQUE ISSUES. DUE TO THE DIFFICULTIES, THE PROCEDURE TOOK AN UNUSUALLY LONG TIME AND EXCESSIVE IRRIGANT WAS USED. THE PT HAD ALSO UNDERGONE LITHOTRIPSY TWO WEEKS PRIOR TO THE PERCUTANEOUS PROCEDURE AND THE DAY BEFORE THE PERCUTANEOUS PROCEDURE, A NEPHROSTOMY TUBE WAS PLACED BECAUSE THE KIDNEY WAS NOT DRAINING. CO'S DIRECTIONS FOR USE STATE: "THE COMPLICATIONS WHICH MAY RESULT FROM THE USE OF FORCEPS IN A PROCEDURE INCLUDE: URETERAL PERFORATION URETERAL EVULSION, HEMORRHAGE, KIDNEY PERFORATION AND EDEMA. CAUTION: IF RESISTANCE IS ENCOUNTERED...DO NOT USE EXCESSIVE FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE RETRIEVAL GRASPING FORCEPS/EXTRA STR/HOOK STONE RETRIEVAL GRASPING FORCEPS FFL MICROVASIVE UROLOGY / A DIVISION OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death