BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO

    MDR report key: 16364994 · Received February 13, 2023

    Report

    Report Number
    2183446-2023-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 19, 2023
    Report Date
    February 13, 2023
    Manufacturer
    HANGZHOU AGS MEDTECH CO., LTD.
    Product Code
    FDI
    UDI-DI
    00816734023020
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    NO ADVERSE EVENT RELATED TO THIS INCIDENT. AS THE SNARE WAS CLOSING AROUND THE POLYP, THE SNARE WIRE BROKE OFF FROM THE CATHETER. THE WIRE PIECE WAS RETRIEVED WITH A BIOPSY FORCEPS AND NO PATIENT INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681337 LASSO POLYPECTOMY SNARE FDI HANGZHOU AGS MEDTECH CO., LTD. 1180-12 034921 00816734023020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown