BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPY LESION HUNTER

    MDR report key: 21106202 · Received January 7, 2025

    Report

    Report Number
    MW5164435
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 3, 2025
    Manufacturer
    MICROTECH (NANJING) CO., LTD.
    Product Code
    GAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    10MM COLD SNARE LESION HUNTER BROKE OFF INTO PATIENT WHILE TRYING TO OBTAIN COLON POLYP. PIECE REMOVED FROM PATIENT SAFELY WITH BIOPSY FORCEPS BY DR. CONFIRMED BY SURGICAL TEAM, MANAGEMENT NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323515 ENDOSCOPY LESION HUNTER SNARE, SURGICAL GAE MICROTECH (NANJING) CO., LTD. M240612303

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male