BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTECH

    MDR report key: 10683225 · Received October 14, 2020

    Report

    Report Number
    MW5097220
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 2, 2020
    Manufacturer
    MICRO-TECH (NAN JING) CO., LTD.
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE EVENT THAT HAPPENED WITH BOTH DEVICES WAS THERE WAS A HOLE IN THE CATHETER WHICH ALLOWED THE SPOT INK TO SPILL OUT AND NOT BE INJECTED IN THE MUCOSA . NO HARM WAS CAUSED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146322 MICROTECH ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK MICRO-TECH (NAN JING) CO., LTD. IN12-255232302 M190826326
    1146323 MICROTECH ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK MICRO-TECH (NAN JING) CO., LTD. IN12-255232302 M202313325

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR