BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC PROBE

    MDR report key: 3925159 · Received June 20, 2014

    Report

    Report Number
    9610617-2014-00032
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    March 26, 2014
    Report Date
    June 20, 2014
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    FEO
    PMA / PMN Number
    K843101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, WHILE PERFORMING A STONE FRAGMENTATION PROCEDURE, THE TIP OF THE PROBE CAME OFF INTO PATIENT. DOCTOR IMMEDIATELY RETRIEVED. PROCEDURE WAS COMPLETED WITH NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363129 ULTRASONIC PROBE ULTRASONIC PROBE FEO KARL STORZ GMBH & CO. 27093LL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention