BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO

    MDR report key: 16112410 · Received January 6, 2023

    Report

    Report Number
    2183446-2023-00001
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    November 14, 2022
    Report Date
    January 6, 2023
    Manufacturer
    HANGZHOU AGS MEDTECH CO., LTD.
    Product Code
    FDI
    UDI-DI
    00816734021576
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED THIS ADVERSE EVENT TO IMPORTER ON DECEMBER 8, 2022. CUSTOMER REPORTED A PERFORATION DURING THE REMOVAL OF POLYPS FROM THE COLON. THE PROCEDURE BEING PERFORMED WAS A COLONSCOPY WITH A POLYPECTOMY X 2 (HEPATIC FLEXURE AND SIGMOID). THE ADVERSE EVENT REQUIRED A REPORTED SURGICAL INTERVENTION TO REPAIR THE PERFORATION. THE PATIENT HAD NO REPORTED UNDERLYING HEALTH ISSUES THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PATIENT WAS HOSPITALIZED FOR 9 DAYS TOTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393024 LASSO POLYPECTOMY SNARE FDI HANGZHOU AGS MEDTECH CO., LTD. 1180-02 041926 00816734021576

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R