BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE RETRIEVAL DEVICE

    MDR report key: 12952926 · Received December 6, 2021

    Report

    Report Number
    MW5105844
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    September 27, 2021
    Report Date
    December 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UROLOGY STONE BASKET BROKE UPON NORMAL URETERAL STONE RETRIEVAL. ALL EQUIPMENT PIECES INTACT, NO HARM DONE TO PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843305 STONE RETRIEVAL DEVICE DISLODGER, STONE, BASKET, URETERAL, METAL FFL OLYMPUS MEDICAL SYSTEMS CORP. 92100558

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female