BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LESION HUNTER ROTATABLE NITINOL COLD SNARE 10 MM

    MDR report key: 21884411 · Received April 22, 2025

    Report

    Report Number
    MW5169419
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 15, 2025
    Report Date
    April 18, 2025
    Manufacturer
    MICRO-TECH (NANJING) CO., LTD.
    Product Code
    GAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FLEXIBLE SNARE TIP BROKE OFF INSIDE PATIENT'S COLON DURING ATTEMPT TO USE DEVICE TO REMOVE A POLYP BY PHYSICIAN AND SURGICAL TECH. SNARE TIP NOT RETRIEVED, NO DETECTABLE HARM TO PATIENT. LESION HUNTER ROTATABLE NITINOL COLD SNARE 10 MM LOT M240815304, EXP:08/14/2029, DATE OF MANUFACTURE: 08-15-2024 REF: CS2-2102323.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273997 LESION HUNTER ROTATABLE NITINOL COLD SNARE 10 MM SNARE, SURGICAL GAE MICRO-TECH (NANJING) CO., LTD. M240815304

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other