BEUDAMED
    FDA Adverse Event Other Summary report: N

    NCOMPASS NITINOL STONE EXTRACTOR

    MDR report key: 1239066 · Received November 11, 2008

    Report

    Report Number
    1825146-2008-00036
    Event Type
    Other
    Date Received
    November 11, 2008
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A PROPER EVALUATION CANNOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED. ONE STONE EXTRACTOR WAS PULLED FROM STOCK AND EVALUATED; THE BASKET WAS NOTED TO FULLY DEPLOY AND FUNCTION AS INTENDED, WITHIN SPECIFICATION. THE INITIAL PROCEDURE OCCURRED APPROXIMATELY (B) (6) 2008. ADDITIONAL INFORMATION RECEIVED INDICATES THE LOT NUMBER WILL NOT BE AVAILABLE DUE TO THIS FACILITY NOT KEEPING THAT INFORMATION FOR STONE EXTRACTORS. WHEN SPEAKING WITH THE PHYSICIAN INVOLVED, HE REPORTED, "THE PATIENT IS DOING WELL". WE DID ESWL, THE STONE CRACKED AND SHAPED IN SHAPE. PERFORMED CYSTOSCOPE AFTERWARD AND THE BLADDER HAD NO SIGNS OF IRRITATION. PULLED REMAINING WIRES FROM BASKET OUT OF THE BLADDER THROUGH THE URETHRA, TUGGED AT THE WIRES, BUT COULD NOT RETRIEVE THE BASKET. WENT IN WITH URETEROSCOPE, NO BLEEDING NOTED, USED HOLMIUM LASER FIBER TO TAKE THE STONE DOWN TO SAND. FIRST STONE WAS GONE, REALIZED THAT THE EXTRACTOR WAS ENVELOPING ALL THREE STONES. THE EXTRACTOR REMAINED INTACT EXCEPT WHERE I CUT THE HANDLE PREVIOUSLY. AFTER STONES AND EXTRACTOR WERE PULLED OUT, DID A RELOOK OF THE KIDNEY AND URETER AND SAW NO SIGN OF INJURY. STENTED THE PATIENT WITH THE NYLON STRING AND PULLED IT OUT AFTER THREE DAYS. NO PROBLEMS AT ALL". WHEN THE PHYSICIAN WAS ASKED ABOUT THE FUNCTION OF THE EXTRACTOR HE STATED, "I THOUGHT I WAS GRABBING ONE STONE, BUT I WAS GRABBING THE TOP STONE INSTEAD AND GOT ALL THREE". BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN INVOLVED IN THE CASE, IT APPEARS HE DID NOT REALIZE HOW MANY STONES HE HAD RETRIEVED AND COULD NOT GET A 'GOOD' ANGLE ON THE STONES WITH A LASER WITHOUT POSSIBLE DAMAGED TO THE URETER; THE PHYSICIAN DECIDED TO REMOVE AT A LATER DATE; (B) (6) 2008. IT APPEARS THAT THE STONE EXTRACTOR INVOLVED PERFORMED AS INTENDED DURING THE INITIAL CASE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    THREE STONES IN PLACE IN THE UPPER URETER. THE EXTRACTOR WAS STUCK AROUND ONE OF THE STONES AND THE DOCTOR WAS UNABLE TO GET THE ANGLE NEEDED TO GET A 365 MICRON LASER FIBER TO BREAK UP THE STONE DURING THE ORIGINAL PROCEDURE TWO DAYS AGO. THE DOCTOR STATES IT WAS ALWAYS POINTING AT THE WALL OF THE URETER SO I WAS NOT ABLE TO GET THE STONE. THE DOCTOR CUT THE EXTRACTOR AT THE HANDLE AND COILED THE WIRES IN THE PATIENT'S BLADDER LEAVING THE EXTRACTOR IN PLACE AROUND THE STONE. DR (B) (6) REPORTS THE PATIENT ALSO HAS A STENT IN PLACE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCOMPASS NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK UROLOGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention