BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE¿

    MDR report key: 2967768 · Received February 19, 2013

    Report

    Report Number
    3005099803-2013-00805
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AN ESCAPE RETRIEVAL BASKET USED DURING A PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE BASKET WOULD NOT OPEN OR CLOSE. IT IS UNKNOWN IF THERE WAS A STONE IN THE BASKET WHEN THE DEVICE WAS UNABLE TO OPEN. IT IS ALSO UNKNOWN IF THIS EVENT TOOK PLACE INSIDE OR OUTSIDE THE PATIENT OR HOW THE PROCEDURE WAS COMPLETED. THE STATUS OF THE PATIENT AND IF THERE WERE ANY COMPLICATIONS IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71280 ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010 15565583

    Patients

    Seq Age Sex Outcome Treatment
    1