BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLAY

    MDR report key: 18456613 · Received January 5, 2024

    Report

    Report Number
    2183446-2024-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    December 6, 2023
    Report Date
    January 5, 2024
    Manufacturer
    HANGZHOU AGS MEDTECH CO., LTD.
    Product Code
    PKL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A ROUTINE COLONOSCOPY, THE HEMOSTASIS CLIP MALFUNCTIONED DURING DEPLOYMENT, EXPOSING A PIECE OF WIRE AT THE MOST PROXIMAL END OF THE DEPLOYED CLIP. THE CLIP WOULD NOT DEPLOY OR CLOSE PROPERLY AND FELL OFF IN THE GI TRACT. THE CLIP WAS RETRIEVED WITH A NET DURING THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT, BUT THE PRODUCT PROBLEM RESULTED IN AN EXPOSED WIRE WITHIN THE GI TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637701 REPLAY HEMOSTASIS CLIP, GI PKL HANGZHOU AGS MEDTECH CO., LTD. 1170-01 069597

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown