BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCIS GUIDANCE SYSTEM

    MDR report key: 15128627 · Received July 29, 2022

    Report

    Report Number
    3012787974-2021-80037
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    September 3, 2020
    Report Date
    July 29, 2022
    Manufacturer
    NEOCIS INC.
    Product Code
    PLV
    UDI-DI
    00810004900004
    PMA / PMN Number
    K161399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. LOGFILE ANALYSIS WAS PERFORMED AND THERE WAS NO INDICATION OF A SYSTEM ISSUE THAT COULD BE CAUSING THE GUIDE ARM TO MOVE INVOLUNTARY. THE MOVEMENT DOWNWARD WAS CONFIRMED AS WELL AS THE ABRUPT STOP DUE TO FORCES APPLIED. THERE WAS NO INDICATION OF UNUSUALLY HIGH FORCES REGISTERED IN THE FORCE TORQUE SENSOR DURING THE DOWNWARD MOVEMENT. REVIEW OF LOGFILES NOTED A SAFETY PAUSE OCCURRED AS A RESULT OF UNSAFE LEVELS OF FT. WITH REVIEW OF AVAILABLE INFORMATION, IT IS LIKELY THE SAFETY PAUSE WAS AS A RESULT OF THE PHYSICAL INTERVENTION PERFORMED BY SURGEON. FIELD SERVICING WAS PERFORMED ON 09/08/2020 AND THE GUIDE ARM WAS FOUND TO BE OUT OF CALIBRATION. THE SYSTEM WAS RE-CALIBRATED AND CONFIRMED TO BE WITHIN ACCURACY SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THE INVOLUNTARY MOVEMENT COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES COULD BE ATTRIBUTED TO PULLING OF THE FORCE TORQUE SENSOR CABLE, INVOLUNTARY FORCE APPLIED TO THE GUIDE ARM, TRACKER ARM, OR GUIDE ARM OUT OF CALIBRATION. THERE WAS NO INDICATION OF PATIENT INJURY AS A RESULT OF THIS EVENT. ISSUES OF THIS NATURE HAVE BEEN TRACKED AND TRENDED TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    NEOCIS PERFORMED RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS AND REEVALUATED MDR REPORTABILITY. THIS REPORT IS BEING SUBMITTED AS A RESULT OF THIS RETROSPECTIVE REVIEW. IT WAS REPORTED THAT DURING A DENTAL IMPLANT PROCEDURE WITH THE NEOCIS GUIDANCE SYSTEM (NGS), THE USER HIT A WRIST SINGULARITY AND THE SYSTEM WENT INTO A DRIFT DOWNWARD POSITION AND THE SURGEON WAS UNABLE TO RE-ORIENT THE GUIDE ARM. THE SURGEON LIFTED THE ROBOT OFF THE FLOOR WITH HIS TWO HANDS BY HOLDING THE GUIDE ARM. THE WRIST OF THE GUIDE ARM TAPPED THE PATIENT ON THE ORBITAL ASPECT JUST ABOVE THEIR LEFT EYE LID. THE SAFETY PAUSE ALARM ENGAGED, AND THE TEAM RAISED THE ROBOT USING THE UPPER CONTROLS. THE BRAKE WAS UNLOCKED AND PULLED THE ROBOT AWAY. DURING THE ACTION OF RAISING THE ROBOT THE CHAIRSIDE PATIENT SPLINT (CPS) DISLODGED FROM THE PATIENT'S MOUTH. NO DAMAGE WAS CAUSED TO THE PATIENT BY THE DISLODGING OF THE SPLINT. THE CASE WAS COMPLETED FREE HAND. NO FURTHER PATIENT COMPLICATIONS OR DEVICE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095815 NEOCIS GUIDANCE SYSTEM DENTAL STEREOTAXIC INSTRUMENT PLV NEOCIS INC. GEN 1 00810004900004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention