BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTURA HELICAL STONE EXTRACTOR

    MDR report key: 1812341 · Received August 12, 2010

    Report

    Report Number
    1825146-2010-00030
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 12, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED PACKAGE CONTAINING A USED STONE EXTRACTOR WAS RECEIVED ALONG WITH A SPECIMEN CUP CONTAINING A SMALL CLEAR TUBE. THE CLEAR TUBE SHOULD HAVE MEASURED 1CM IN LENGTH AND WAS NOTED TO BE ACCORDION DOWN TO 5MM. SCRAPE MARKS WERE OBSERVED ON THE BASKET SHEATH LEADING TO THE LOCATION OF THE CLEAR TUBE. THE SHRINK TUBE WAS MOST LIKELY PULLED OFF AND THE BASKET SHEATH WAS DAMAGED WHEN BEING REMOVED ON AN INSTRUMENT OF UNDETERMINED ORIGIN. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    TODAY DURING A CYSTO STONE MANIPULATION CASE, THE DOCTOR INDICATED THE LITTLE PLASTIC PIECE ON THE END OF THE STONE EXTRACTOR POPPED OFF WHEN PULLING THE STONE EXTRACTOR BACK THROUGH THE SCOPE. THE PLASTIC PIECE WAS REMOVED FROM THE PATIENT'S BLADDER USING A GRASPING FORCEP. NUMEROUS COMPLAINTS HAVE BEEN LOGGED FOR THIS SAME ISSUE AND THE DOCTOR NO LONGER WANTS THIS DEVICE AND IS GOING TO USE BOSTON SCIENTIFIC UNTIL COOK FIXES THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURA HELICAL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK UROLOGICAL, INC. NA U1956499

    Patients

    Seq Age Sex Outcome Treatment
    1