BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI STONE RETRIEVAL PAIRED WIRE/HELICAL

    MDR report key: 1181607 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04856
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE SUSPECT DEVICE; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK. ALTHOUGH THE DEVICE HAS BEEN RECEIVED THE DEVICE HAS NOT BEEN EVALUATED, THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON AUG 26, 2008, THAT A GEMINI STONE RETRIEVAL PAIRED WIRE/HELICAL BASKET WAS BEING PREPARED FOR A URETEROSCOPY PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT THE BASKET WOULD NOT OPEN OR CLOSE WHEN THEY TESTED IT OUTSIDE THE PT. THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI STONE RETRIEVAL PAIRED WIRE/HELICAL FFL BOSTON SCIENTIFIC CORPORATION M0063303060 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK