BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16613563 · Received March 24, 2023

    Report

    Report Number
    2955842-2023-11515
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    February 21, 2023
    Report Date
    February 24, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. AN ADVANCED SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE BY AN ISI ADVANCED FAILURE ANALYSIS ENGINEER (AFA). PER AFA, THERE WERE TWO ADVISORY ERRORS AT 1:02 RELATED TO THE TRUMPF [TRUSYSTEM 7000DV] TABLE. ONE STATES THAT THE REMOTE CENTER MONITOR TERMINATED TABLE MOTION ON ARM [UNIVERSAL SURGICAL MANIPULATOR] 3 AND THE OTHER WAS A DATA LATENCY ERROR. THE 23119 ERROR IS INDICATING THAT USM 3 WAS ¿DRIFTING¿. THIS WAS POSSIBLY DUE TO THE CANNULA NOT BEING IN CONTACT WITH THE PATIENT. DISABLING TABLE MOTION IS DESIRED BEHAVIOR IN THIS SITUATION. THE 23122 ERROR INDICATES THE CONNECTION WAS INTERRUPTED (LATENCY). THE CAUSE OF THIS WAS THE PREVIOUS 23119 ERROR INTERRUPTING TABLE MOTION. TABLE MOTION WAS LIKELY ACTIVATED CAUSING THE USMS THAT ARE FREE TO MOVE TO ¿DRIFT¿. THIS INCLUDES USM 1 AND USM 4. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATORS (USM) DID NOT FOLLOW TABLE MOTION. THE ISSUE OCCURRED WHEN THE PORTS CONNECTED TO USM1 AND USM4 CAME OUT OF THE PATIENT WHEN THE THIRD-PARTY HILLROM TRUSYSTEM 7000DV OPERATING TABLE WAS BEING POSITIONED INTO LOW TRENDELENBURG. WHEN THE TABLE WAS RETURNED TO SUPINE POSITION, THE PORTS REINSERTED INTO THE PATIENT. THE CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATORS (USM) DID NOT FOLLOW TABLE MOTION. THE ISSUE OCCURRED WHEN THE PORTS CONNECTED TO USM1 AND USM4 CAME OUT OF THE PATIENT WHEN THE THIRD-PARTY HILLROM TRUSYSTEM 7000DV OPERATING TABLE WAS BEING POSITIONED INTO LOW TRENDELENBURG. WHEN THE TABLE WAS RETURNED TO SUPINE POSITION, THE PORTS REINSERTED INTO THE PATIENT. A ¿READY FOR TABLE MOTION¿ MESSAGE WAS NOT SEEN ON THE VIDEO SIDE CONSOLE TOUCHSCREEN, THE SOUND OF RELEASED BRAKES AND THE PATIENT SIDE CONSOLE USM LOCKING SOUND WERE NOT HEARD, AND THE SURGEON MAY NOT HAVE BEEN IN FOLLOWING MODE AT THE TIME. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; PER THE DIRECTOR OF THE GYNECOLOGICAL ONCOLOGY DEPARTMENT, THE PATIENT DID NOT EXPERIENCE AN INJURY DUE TO THE EVENT AND IS DOING WELL POST-OPERATIVELY. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS, AND NO INTERVENTION WAS REQUIRED. NO TISSUE OR VESSELS WERE DAMAGED. THERE WAS NO BLEEDING. THE PROCEDURE WAS DELAYED BY A FEW MINUTES TO RE-DOCK THE INVOLVED PORTS. THE ISSUE DID NOT DELAY A CRITICAL PART OF THE PROCEDURE. THERE WERE NO POST-OPERATIVE COMPLICATIONS. THE TS7000DV OPERATING TABLE AND DA VINCI SYSTEM RECOGNIZED EACH OTHER WHEN POWERED ON AS INDICATED BY THE DV BUTTON ON THE TABLE REMOTE CONTROL BEING ILLUMINATED. PAIRING FOR INTEGRATED TABLE MOTION (ITM) WAS INITIATED BY THE ¿ME¿ WITH THE TABLE REMOTE CONTROL AND THE WIRELESS PAIRING WAS CONFIRMED BY THE OPERATING ROOM NURSE. AFTER CONFIRMED ITM WITH THE SURGEON, THE ANESTHESIOLOGIST PRESSED THE DV BUTTON ON THE TABLE REMOTE CONTROL AND THE ¿TABLE MOTION ACTIVATION¿ MESSAGE WAS HEARD FROM THE DA VINCI SYSTEM. PER THE ANESTHESIOLOGIST, HE DID NOT UNLOCK THE TABLE AND IT DID NOT UNPAIR WITH THE DA VINCI ROBOT. A HILLROM ENGINEER REVIEWED THE TABLE ERROR LOGS AND DID NOT OBSERVE A HISTORY OF DISCONNECTION ERROR. THERE IS NO REPORT OF ANY MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375355 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-54 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES