BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16057743 · Received December 27, 2022

    Report

    Report Number
    2955842-2022-16146
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    November 28, 2022
    Report Date
    November 29, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 STOWED ITSELF, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS CONFIRMED IN THE SYSTEM LOGS; HOWEVER, IT WAS NOT REPRODUCED BASED ON THE FIELD EVALUATION. THE FSE REPLACED THE PROXIMAL SET UP JOINT (SUJ) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS WAS UNABLE TO REPRODUCE THE REPORTED COMPLAINT, HOWEVER, THE ERROR WAS CONFIRMED VIA FIELD LOGS. THE UNIT WAS ABLE TO PASS BRAKE VERTICAL, ENCODER VERTICAL AND Z TWANG TESTS ON THE PSC FIXTURE TEST PLATFORM (PFTP). THE UNIT WAS ALSO CALIBRATED ON THE PFTP WITH NO ISSUES. AFTER PFTP CALIBRATION, THE UNIT WAS INSTALLED ONTO A SYSTEM AND WAS ABLE TO START IN NORMAL MODE AND GO THROUGH ITS FULL RANGE OF MOTION (ROM) WITH NO ERRORS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. A PROCEDURE LOG REVIEW CONFIRMED A BILATERAL INGUINAL HERNIA PROCEDURE TOOK PLACE ON (B)(6) 2022 ON SYSTEM SK5922. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). A REVIEW OF THE SITE¿S SYSTEM LOGS REVEALED ERROR 23062 - A 3 PHASE MOTOR DID NOT RESPOND AS EXPECTED ON THE USM3, SUJ Z-AXIS GRAVITY MOTOR (SUJ PROXIMAL). (INCONSISTENT MOTOR CURRENT, VOLTAGE AND SPEED.) FAULTY MOTOR, ENCODER, AMPLIFIER OR CONNECTION. THE PROBABLE ROOT CAUSE OF USM3 STOWED ITSELF IS ATTRIBUTED TO A DEFECTIVE VERTICAL SET UP JOINT. THE PROXIMAL VERTICAL SET UP JOINT WAS REPLACED AS A FIX. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE UNIVERSAL SURGICAL MANIPULATOR (USM) MOVED WITH UNINTUITIVE MOTION DURING A DA VINCI SURGICAL PROCEDURE. THE UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WHILE THE SURGEON WAS TRYING TO SUTURE. IT SEEMED AS IF THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 ATTEMPTED TO STOW ITSELF AND BECAME UNRESPONSIVE. THE TSE REVIEWED LOGS AND CONFIRMED 23062 FAULTS IN THE LOGS. THE SITE WAS ABLE TO COMPLETE THE CASE BUT WANTED TO MAKE THE ISI FIELD SERVICE ENGINEER (FSE) AWARE OF THE SITUATION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE INITIAL REPORTER SAID THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO INJURY OR HARM TO THE PATIENT. TROUBLESHOOTING WAS NOT PERFORMED, AND THEY DID NOT CALL TECHNICAL SUPPORT AT THE TIME OF ISSUE. ARM 3 WAS DISABLED. THE SURGEON TRIED TO MANUALLY CUT THE SUTURE OFF. THE SURGEON DID NOT MANUALLY SUTURE BUT DID MANUALLY CUT THE SUTURE THREAD. THE PROCEDURE WAS COMPLETED USING 3 ARMS. DO NOT KNOW WHAT INSTRUMENT WAS USED ON ARM 3. PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139683 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.