BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE 3 FRENCH 10MM CONE

    MDR report key: 1140886 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04028
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANS-URETERAL LITHOTRIPSY (TUL) PROCEDURE, THE DEVICE FAILED TO OPEN. THE LOCATION OF THE LESION IS UNKNOWN. THE STONE CONE 3FR. RETRIEVAL COIL WAS ADVANCED TO THE LESION AND THE ENDOSCOPE WAS REMOVED. UPON ATTEMPTING TO RETRACT THE SHEATH TO OPEN THE COIL, THE OUTER SHEATH WAS "STUCK" AND THE PHYSICIAN WAS UNABLE TO OPEN THE COIL. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE 3 FRENCH 10MM CONE FGO BOSTON SCIENTIFIC M0063903200

    Patients

    Seq Age Sex Outcome Treatment
    1