BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTH NET

    MDR report key: 20223874 · Received September 16, 2024

    Report

    Report Number
    20223874
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 13, 2024
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: ROTH NET WOULD NOT DEPLOY IN THE PATIENT. METAL ACTUALLY BENT IN THE HANDLE. MINI ROTH NET REF # 00711057, LOT # 9014169.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113562 ROTH NET SNARE, FLEXIBLE FDI UNITED STATES ENDOSCOPY GROUP, INC. 00711057 9014169

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male