BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 4269426 · Received October 16, 2014

    Report

    Report Number
    1221826-2014-00050
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 16, 2014
    Manufacturer
    KARL STORZ ENDOVISION, INC.
    Product Code
    FBO
    PMA / PMN Number
    K062918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE FLEXIBLE URETEROSCOPE HAS A MANUFACTURING DATE OF JULY 2011. IT WAS SHIPPED TO A DIFFERENT FACILITY IN (B)(4) 2012 AND NOT (B)(6). THEIR RISK MANAGER CONFIRMED THAT (B)(4) IS THE THIRD PARTY REPAIR COMPANY THEY USED FOR REPAIR OF THIS SCOPE AND OTHER REPAIRS.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A KIDNEY STONE REMOVAL PROCEDURE, DOCTOR NOTICED A SMALL WHITE FOREIGN BODY IN THE KIDNEY. HE WAS UNABLE TO IDENTIFY OR REMOVE FOREIGN OBJECT DURING THE CASE. LATER, HE IDENTIFIED THAT SCOPE USED FOR THE PROCEDURE WAS MISSING A SMALL INNER WHITE SLEEVE FROM DISTAL TIP. A WEEK LATER, HE SCHEDULED AN URETEROSCOPY TO REMOVE A STENT AND RETRIEVED SMALL WHITE PIECE AT THAT TIME. PROCEDURE WAS COMPLETED WITH NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656663 KARL STORZ FLEXIBLE URETEROSCOPE FBO KARL STORZ ENDOVISION, INC. 11278AU1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention