BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO-TECH ENDOSCOPY INJECTION NEEDLE

    MDR report key: 18799723 · Received February 27, 2024

    Report

    Report Number
    MW5152104
    Event Type
    Other
    Date Received
    February 27, 2024
    Date of Event
    February 22, 2024
    Report Date
    February 22, 2024
    Manufacturer
    MICRO-TECH (NANJING) CO., LTD.
    Product Code
    FBK
    UDI-DI
    06932503533249
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INJECTION NEEDLE HAS A CLEAR TIP COVER THAT IS THE SAME COLOR AS THE TUBING AND EASILY FITS THROUGH THE SCOPE CHANNEL. THE USER INADVERTENTLY FORGOT TO REMOVE THE TIP COVER AND THE TIP CAME OFF IN THE PATIENTS COLON AND HAD TO BE RETRIEVED. THERE WAS NO INJURY TO PATIENT DUE TO THIS ERROR. RECOMMEND TIP COVER COLOR AND SIZE BE REVISED TO AVOID FUTURE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496970 MICRO-TECH ENDOSCOPY INJECTION NEEDLE ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK MICRO-TECH (NANJING) CO., LTD. IN33240 M230117321 06932503533249

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female