BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASKET, ZERO TIP NITINOL STONE RETRIEVAL

    MDR report key: 2150420 · Received June 22, 2011

    Report

    Report Number
    2150420
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A RIGHT URETEROSCOPY. THE MD INSERTED A STONE RETRIEVAL BASKET FOR REMOVAL OF A URETERAL STONE. THE BASKET WOULD NOT OPEN. IT WAS REMOVED AND A NEW STONE RETRIEVAL BASKET WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASKET, ZERO TIP NITINOL STONE RETRIEVAL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR