BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK

    MDR report key: 1061854 · Received June 17, 2008

    Report

    Report Number
    MW5007327
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 3, 2008
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A RIGHT URETEROSCOPY WITH HOLMIUM YAG LASER, LASER LITHOTRIPSY, EXTRACTION OF URETERAL STONE. THE PT HAD MULTIPLE STONES WHICH WERE FRAGMENTED USING LASER LITHOTRIPSY. SEVERAL FRAGMENTS WERE REMOVED USING A STONE BASKET. THERE WAS 1 STONE WHICH HAD MIGRATED UP TO THE RENAL PELVIS. THIS WAS GRASPED WITH THE NITINOL STONE BASKET. THE BASKET BECAME ENTRAPPED IN THE MID URETER IN THE REGION OF THE SACROILIAC JOINT. MULTIPLE ATTEMPTS WERE MADE TO RELEASE THE STONE FROM THE BASKET WITHOUT SUCCESS. THE BASKET WAS THEN DISASSEMBLED AND THE URETEROSCOPE WAS ADVANCED TO THE STONE AND THE AREA WAS TREATED WITH LASER LITHOTRIPSY. CARE WAS TAKEN TO ENSURE THAT THE BASKET WAS NOT VIOLATED. FURTHER MANIPULATION WAS DONE AND THE BASKET RELEASED. IT WAS NOTED THAT THE BASKET HAD BROKEN OFF FROM THE STEM. SEVERAL FRAGMENTS OF WIRE FROM THE BASKET WERE ALSO NOTED. MULTIPLE ATTEMPTS WERE MADE TO GRASP THE FRAGMENTS WITHOUT SUCCESS. THE CASE WAS THEN CONVERTED TO AN OPEN PROCEDURE. THE SECOND PROCEDURE WAS AN OPEN EXPLORATION, OPEN URETEROLITHOTOMY AND REMOVAL OF STONE BASKET. THE PT DID WELL POSTOPERATIVELY AND WAS DISCHARGED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK COOK N-CIRCLE NITINOL TIPLESS STONE EXTRACTOR DQO COOK UROLOGICAL, INC. NTSE-030115-UDH U1710494 3 FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization