BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15 MM LESIONHUNTER ROTATABLE NITINOL COLD SNARE

    MDR report key: 20522940 · Received October 23, 2024

    Report

    Report Number
    MW5161508
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 15, 2024
    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

    15 MM LESION HUNTER ROTATABLE NITINOL COLD SNARE LOT: M240116301 // EXPIRATION: 10-15-2029. LESION HUNTER SIZE 15 MM SNARE SNAPPED IN HALF WHEN RETRIEVING POLYP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578905 15 MM LESIONHUNTER ROTATABLE NITINOL COLD SNARE SNARE, SURGICAL GAE MICRO-TECH (NANJING) CO., LTD. M240116301

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other