BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19702245 · Received July 9, 2024

    Report

    Report Number
    2955842-2024-16689
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 12, 2024
    Report Date
    June 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DVSTREAM LOG AND KINEMATIC DATA LOGS ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED, AND THE REVIEW OF THE DATA INDICATES THAT THE INCIDENT OCCURRED WHILE THE SURGEON¿S HEAD WAS IN THE CONSOLE AND HANDS WEREN¿T ON CONTROLS. THERE WEREN¿T ANY RELATED ERRORS. AS A RESULT, THE MASTER TOOL MANIPULATORS (MTM¿S) WILL HAVE THE ABILITY TO DRIFT DUE TO GRAVITY. THE MTM AXIS-1 IS NOT GRAVITY COMPENSATED AND IS SUSCEPTIBLE TO OR FLOORS THAT AREN¿T LEVEL. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER DID RE-CALIBRATE THE MTM DURING THEIR SITE VISIT AS WELL. THE DA VINCI XI SURGICAL SYSTEM USER MANUAL STATES THE FOLLOWING REGARDING HEAD-IN REQUIREMENT: TO BEGIN USING THE HAND CONTROLS, THE SURGEON MUST FIRST PUT THEIR HEAD IN THE 3D VIEWER. THE 3D VIEWER USES A PAIR OF INFRARED HEAD SENSORS TO DETERMINE WHETHER THE SYSTEM IS IN USE OR NOT. IF THE SURGEON¿S HEAD IS OUT OF THE VIEWER, HE OR SHE CANNOT TAKE CONTROL OF THE INSTRUMENTS OR ENDOSCOPE. CAUTION: DO NOT LET GO OF THE HAND CONTROLS WHILE THE SURGEON¿S HEAD IS STILL IN THE VIEWER, BECAUSE DOING SO MAY CAUSE PATIENT TISSUE DAMAGE.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE. THE FSE REVIEWED THE SYSTEM LOGS AND FOUND NO RELATED ERRORS. THE FSE ALSO CALIBRATED AND SWAPPED THE LEFT MTML WITH THE RIGHT MTM; NO REPLACEMENTS PARTS WERE REQUIRED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. SYSTEM AND INSTRUMENT LOG REVIEWS CANNOT BE PERFORMED AT THIS TIME DUE TO INSUFFICIENT PROCEDURE INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, THERE WAS AN UNINITIATED DRIFT MOTION OF THE LEFT MASTER TOOL MANIPULATOR (MTM). WHEN THE SURGEON PLACED HIS HEAD IN THE HIGH-RESOLUTION STEREO VIEWER (HRSV) ON THE SURGEON SIDE CONSOLE (SSC) AND RELEASED HIS FINGERS, THE RIGHT MTM DID NOT MOVE AND THE LEFT MTM MOVED DOWN AND AWAY SLOWLY. THE UNINITIATED MOVEMENT CAUSED THE INSTRUMENT ATTACHED TO THE UNIVERSAL SURGICAL MANIPULATOR (USM), TO MOVE DOWNWARD AND THE BLADDER WAS INJURED. THERE WAS NO BLEEDING AND THE BLADDER WAS REPAIRED USING SUTURES. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE; AND THERE WERE NO EXTERNAL COLLISIONS THAT OCCURRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THERE WERE NO POST-OPERATIVE COMPLICATIONS. THE MTM ISSUE WAS TEMPORARY AND COULD NOT BE REPRODUCED AFTER THE COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499051 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-27 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES