BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 22469879 · Received July 10, 2025

    Report

    Report Number
    3000719653-2025-00007
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 10, 2025
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461090910
    PMA / PMN Number
    K250877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF A ROBOTIC PROCEDURE, THE HOSPITAL REPORTED THAT THE PLASTIC FRICTION WASHER OF THE ARRAY BRACKET WAS FOUND TO BE DAMAGED AND HAD DETACHED DURING DISASSEMBLY AND TRANSFER OUT OF THE STERILE FIELD. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT, AND NO HARM WAS REPORTED TO THE PATIENT AND STAFF. THE INTERNAL INVESTIGATION OF THE ARRAY BRACKET SHOWED THAT THE WASHER WAS MISSING AS IT WAS REPORTED AND CONFIRMED BY THINK SURGICAL CLINICAL REPRESENTATIVE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION, AS THE WASHER FAILED STRUCTURALLY. ALTHOUGH NO HARM OCCURRED IN THIS INSTANCE, THERE IS A POTENTIAL THAT THE WASHER COULD DETACH AND FALL INTO THE STERILE FIELD OR SURGICAL SITE DURING A PROCEDURE.

    Description of Event or Problem · 0

    UPON CONCLUSION OF A SUCCESSFULLY COMPLETED ROBOTIC CASE, THE STAFF NOTICED THE PLASTIC FRICTION RING OF THE ARRAY BRACKET WAS DAMAGED AND COMING OFF THE BRACKET DURING DISASSEMBLY AND TRANSFER TO THE BACK TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978988 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 109091 22068 M9461090910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown