BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSOLUTION ONE TOTAL KNEE APPLICATION

    MDR report key: 15899274 · Received December 1, 2022

    Report

    Report Number
    3000719653-2022-00007
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    November 2, 2022
    Report Date
    December 1, 2022
    Manufacturer
    THINK SURGICAL INC.
    Product Code
    OLO
    PMA / PMN Number
    K203040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO PRODUCT MALFUNCTIONS REPORTED. THE USER DID NOT RETRACT THE SOFT TISSUE WHILE THE ROBOT WAS CUTTING AS RECOMMENDED IN THE IFU. THE IFU PROVIDE THE WARNING THAT FAILURE TO PROVIDE ADEQUATE SOFT TISSUE RETRACTION OR OTHER METHODS OF PROTECTION FOR CRITICAL SOFT TISSUE CAN CAUSE SOFT TISSUE DAMAGE. THE IFU ALSO RECOMMENDS THAT BONE PREPARATION, THE SURGEON SHOULD EVALUATE IF ADDITIONAL SOFT-TISSUE RETRACTION IS NEEDED. AS WELL AS A SECTION DEDICATED TO RESETTING SOFT-TISSUE RETRACTORS. THE IMPACT TO THE SOFT TISSUE WAS A NICK ALONG THE INCISION LINE, AND WAS COMPENSATED FOR UPON SUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING FIRST FEMUR CUT, THE TISSUE OF THE PATIENT SLIPPED OUT OF SURGEON'S HANDS WHILE HE WAS RETRACTING. THE SKIN WAS NICKED BY CUTTER. THE PATIENT'S BMI WAS 47 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607553 TSOLUTION ONE TOTAL KNEE APPLICATION TCAT OLO THINK SURGICAL INC. 108400

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female