BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-TECH LESION HUNTER

    MDR report key: 17949588 · Received October 16, 2023

    Report

    Report Number
    MW5147024
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    October 12, 2023
    Report Date
    October 12, 2023
    Manufacturer
    MICRO TECH (NAN JING) CO., LTD.
    Product Code
    GAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A COLONOSCOPY, THERE WAS A POLYP FOUND, WE OPENED A COLD SNARE. WHILE TRYING TO REMOVE THE POLYP WITH THE SNARE, THE TIP OF THE SNARE BROKE OFF. IT WAS RETRIEVED FROM THE PATIENT AND SEQUESTERED. THE STAFF IN THE ROOM OPENED A DIFFERENT TYPE OF SNARE AND WAS ABLE TO REMOVE THE POLYP. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97222 MICRO-TECH LESION HUNTER SNARE, SURGICAL GAE MICRO TECH (NAN JING) CO., LTD. CS2-21023231 M230604307

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female LESION HUNGER. THERAPY START AND END DATE.