BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 22162757 · Received June 7, 2025

    Report

    Report Number
    3000719653-2025-00006
    Event Type
    Malfunction
    Date Received
    June 7, 2025
    Date of Event
    April 22, 2025
    Report Date
    June 6, 2025
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461093430
    PMA / PMN Number
    K243285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TMINI ROBOT WAS RETURNED FOR EVALUATION. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY DELAY OR PATIENT HARM. A REVIEW OF THE SYSTEM LOG FILED DID NOT REVEAL ANY REPORTED ERRORS OR ANOMALIES. THE PHYSICAL TRIGGER MECHANISM WAS INSPECTED AND FOUND TO BE INTACT, WITH NORMAL MOVEMENT AND SPRING RETURN. THE DEVICE WAS TESTED USING THE STANDARD TMINI CALIBRATION AND FUNCTIONAL TEST, AND THE DEVICE BEHAVIOR OBSERVED IN THE FIELD COULD NOT BE REPLICATED DURING IN-HOUSE EVALUATION. THE DEVICE FUNCTIONED AS INTENDED DURING ALL IN-HOUSE TESTING. NO ADDITIONAL CORRECTIVE ACTION IS PLANNED AT THIS TIME. ALTHOUGH THE EVENT RESULTED IN NO PATIENT HARM AND DEVICE FUNCTIONED AS INTENDED DURING IN-HOUSE EVALUATION, THE REPORTED BEHAVIOR - UNINTENDED CHUCK ACTUATION DURING SURGERY - COULD POTENTIALLY LEAD TO A DELAY OR DIFFICULTY IN THE PROCEDURE IF IT WERE TO RECUR; THEREFORE, THINK SURGICAL IS SUBMITTING THIS MEDICAL DEVICE REPORT.

    Description of Event or Problem · 0

    DURING SURGERY, IT SEEMED LIKE THE TMINI ROBOT TRIGGER MECHANISM WAS STUCK. THE PIN WAS SPINNING WHEN THE ROBOT WAS IN THE PROPER POSITION (THE DEVICE IS DESIGNED TO ONLY SPIN THE CHUCK WHEN THE HEAD IS ON PLANE) EVEN WHEN THE SURGEON WAS NOT DEPRESSING THE TRIGGER BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604487 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 109343 M9461093430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown