BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 20092714 · Received August 28, 2024

    Report

    Report Number
    3000719653-2024-00005
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 28, 2024
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461093430
    PMA / PMN Number
    K232802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON WAS INTERVIEWED AND HE STATED THAT THERE WAS A CUTTING ERROR ON THE DISTAL FEMORAL CUT. THE SURGEON CORRECTED THE FEOMORAL CUTS AND FELT THAT THE PATTIENTS BONE QUALITY MAY HAVE BEEN A FACTOR IN THE CUTTING ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE SURGEON NOTICED THAT THE FEMORAL BONE CUTS WERE NOT CONSISTENT WITH THE APPROVED SURGICAL PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494996 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC SURGICAL ROBOT OLO THINK SURGICAL, INC 109343 M9461093430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown