BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONPOINT SYSTEM

    MDR report key: 16214705 · Received January 19, 2023

    Report

    Report Number
    MW5114393
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    January 12, 2023
    Report Date
    January 17, 2023
    Manufacturer
    NEW VIEW SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TROCAR JOINT BROKE - NO LONGER MOVABLE. RETRIEVED USING LAPAROSCOPIC GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412943 VISIONPOINT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ NEW VIEW SURGICAL, INC. NVSV001 26053244

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male