BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLAY

    MDR report key: 20924614 · Received December 13, 2024

    Report

    Report Number
    2183446-2024-00006
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 6, 2024
    Manufacturer
    HANGZHOU, AGS MEDTECH CO, LTD.
    Product Code
    PKL
    UDI-DI
    00816734021491
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A ROUTINE COLONOSCOPY, THE 16MM HEMOSTASIS CLIP MALFUNCTIONED UPON DEPLOYMENT, EXPOSING A PIECE OF WIRE AT THE END OF THE DEPLOYED CLIP. THE CLIP DEPLOYED AND HELD TISSUE AS INTENDED. THE CLIP WAS NOT REMOVED AFTER DEPLOYMENT PER THE DOCTOR, HE FELT IT WAS SAFER TO LEAVE THE CLIP AND LET IT PASS NATURALLY RATHER THAN REMOVE IT. THERE WAS NO PATIENT HARM, BUT THE PRODUCT PROBLEM RESULTED IN AN EXPOSED WIRE WITHIN THE GI TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416580 REPLAY HEMOSTASIS CLIP, GI PKL HANGZHOU, AGS MEDTECH CO, LTD. 1170-02 081262 00816734021491

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown