BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI STONE RETRIEVAL PAIRED WIRE / HELICAL BASKET

    MDR report key: 1951910 · Received January 7, 2011

    Report

    Report Number
    3005099803-2010-05416
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Report Date
    December 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH EXPECTED, THE DEVICE AT ISSUE IN THIS COMPLAINT HAS NOT YET BEEN RECEIVED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. 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 ON (B)(6), 2010 THAT A GEMINI STONE RETRIEVAL PAIRED WIRE HELICAL BASKET WAS USED IN AN UNKNOWN PROCEDURE (PATIENT ID, AGE, GENDER, AND WEIGHT ARE UNKNOWN).ACCORDING TO THE COMPLAINANT, THE DEVICE WAS "DEFECTIVE." SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI STONE RETRIEVAL PAIRED WIRE / HELICAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063303060 13830189

    Patients

    Seq Age Sex Outcome Treatment
    1