BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLAY

    MDR report key: 18191323 · Received November 22, 2023

    Report

    Report Number
    2183446-2023-00005
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 21, 2023
    Manufacturer
    HANGZHOU AGS MEDTECH CO., LTD.
    Product Code
    PKL
    UDI-DI
    00816734021491
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A COLONOSCOPY ON 10-27-2023. ONE 13MM POLYP WAS REMOVED IN THE CECUM AND THE RESECTED AREA WAS CLIPPED. ONE 12MM POLYP WAS REMOVED IN THE MID-ASCENDING COLON AND THAT RESECTED AREA WAS ALSO CLIPPED. THE CLIPS DEPLOYED PROPERLY AND THE EXAMINATION WAS NORMAL ON DIRECT AND RETROFLEXION VIEWS. ON (B)(6) 2023, THE PATIENT RETURNED TO THE ER WITH BLEEDING. ON (B)(6) 2023, THE PATIENT WAS RE-SCOPED. THAT EXAMINATION REPORTED THAT BOTH CLIPS HAD BEEN DISLODGED. NEW CLIPS WERE PLACED IN BOTH AREAS AND NO FURTHER INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744725 REPLAY HEMOSTATIC CLIP FOR THE GI TRACT PKL HANGZHOU AGS MEDTECH CO., LTD. 1170-02 068150 00816734021491

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention