BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO POLYPECTOMY SNARE

    MDR report key: 23416816 · Received October 29, 2025

    Report

    Report Number
    2183446-2025-00001
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 27, 2025
    Report Date
    October 29, 2025
    Manufacturer
    HANGZHOU AGS MEDTECH
    Product Code
    FDI
    UDI-DI
    00816734023020
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    NO ADVERSE EVENT RELATED TO THIS INCIDENT. IT WAS REPORTED TO DIVERSATEK HEALTHCARE THAT A COLD ONLY SNARE COMPLETELY BROKE OFF INSIDE OF A PATIENT WHILE TRYING TO CUT A POLYP. THE WHOLE LOOP FELL OFF WHEN THE SNARE WAS CLOSED. THE WIRE PIECE WAS RETRIEVED AND NO PATIENT INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701571 LASSO POLYPECTOMY SNARE POLYPECTOMY SNARE FDI HANGZHOU AGS MEDTECH 1180-12 098282 00816734023020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown