BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURECLIP

    MDR report key: 11412618 · Received March 4, 2021

    Report

    Report Number
    11412618
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    January 4, 2021
    Report Date
    February 23, 2021
    Manufacturer
    MICRO-TECH (NANJING) CO., LTD.
    Product Code
    PKL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A MICRO-TECH (NANJING) CO., LTD. SURECLIP GASTROINTESTINAL ENDOSCOPIC CLIP WAS DEPLOYED DOWN SCOPE, BUT THE CLIP DID NOT OPEN DURING ITS PLACEMENT. THE SURECLIP GASTROINTESTINAL ENDOSCOPIC CLIP WAS REMOVED INTACT WITHOUT PATIENT RETAINING ANY PARTS OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309299 SURECLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL MICRO-TECH (NANJING) CO., LTD. ROCC-D-26-235-C M2000903238

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA