BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 1698247 · Received May 25, 2010

    Report

    Report Number
    3005099803-2010-02322
    Event Type
    Malfunction
    Date Received
    May 25, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 12, 2010
    Manufacturer
    ACCELLENT ENDOSCOPY JUAREZ
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2010 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE NURSE IN THE PROCEDURE REMOVED THE DEVICE FROM THE PACKAGE WHEN SHE NOTICED A "PIECE OF THE COIL HAD BROKEN OFF." THE ACCOUNT CONFIRMED THERE WAS NO PATIENT CONTACT, HOWEVER ADDITIONAL INFORMATION IS UNAVAILABLE. A SECOND STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS UTILIZED. PLEASE REFERENCE MEDWATCH REPORT NUMBER 3005099803-2010-02323 WHICH DOCUMENTS THE SECOND DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO ACCELLENT ENDOSCOPY JUAREZ M0063903100 0000633335

    Patients

    Seq Age Sex Outcome Treatment
    1