BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE CLIP REPOSITIONABLE HEMOSTASIS CLIP

    MDR report key: 14756543 · Received June 17, 2022

    Report

    Report Number
    MW5110401
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    June 14, 2022
    Report Date
    June 15, 2022
    Manufacturer
    MICRO-TECH (NAN JING) CO., LTD.
    Product Code
    PKL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING EGD/POEM PROCEDURE IN GI LAB, CLIP WAS PLACED DOWN THE WORKING CHANNEL INTO THE PATIENT'S ESOPHAGUS. ATTEMPTED TO OPEN CLIP, UNSUCCESSFUL. CLIP TAKEN OUT OF PATIENT/WORKING CHANNEL AND ATTEMPT MADE TO OPEN CLIP UNSUCCESSFUL. OTHER SUBSEQUENT CLIPS FROM SAME BOX/LOT NUMBER WORKED WITH NO ISSUES. NO HARM TO PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141131 SURE CLIP REPOSITIONABLE HEMOSTASIS CLIP HEMOSTATIC METAL CLIP FOR THE GI TRACT PKL MICRO-TECH (NAN JING) CO., LTD. M201003239

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female