BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15740996 · Received November 5, 2022

    Report

    Report Number
    2955842-2022-15094
    Event Type
    Malfunction
    Date Received
    November 5, 2022
    Date of Event
    October 6, 2022
    Report Date
    October 6, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE INSTRUCTED THE CUSTOMER TO TEST AND SWAP OUT THE ENDOSCOPE AND THIS RESOLVE THE ISSUE. THE SYSTEM WAS CONFIRMED TO BE WORKING WITHIN SPECIFICATION. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED. A LOG REVIEW CONFIRMED THE OCCURRENCE OF A PROCEDURE ON (B)(6) 2022 USING SYSTEM (B)(4). BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER ABORTED AFTER THE START OF THE PROCEDURE DUE TO AN ISSUE RELATED TO VISION. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) REPORTED FROM OFFSITE THAT THE CUSTOMER COULD NOT SEE IN 3D. THE TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED TO CLEAN THE ENDOSCOPE PINS, CHECK SYSTEM CABLE CONNECTION, POWER CYCLE, REPLACE ENDOSCOPE, AND HARD CYCLE SYSTEM IF NECESSARY. THE CUSTOMER CONFIRMED THEY TRIED A POWER CYCLE HOWEVER THERE WAS NO SUCCESS AND OBSERVED A LEFT EYE OUT MESSAGE ERROR DISPLAYED BY THE SYSTEM. BEFORE ANY TROUBLESHOOTING THE SURGEON MADE A DECISION AND ELECTED TO ABORT THE PROCEDURE TO ANOTHER DA VINCI SYSTEM. IT WAS FURTHER REPORTED THAT TSE GUIDED THE CUSTOMER TO HARD POWER CYCLE THE SYSTEM WITH BREAKER RESET ON THE VISION SIDE CART (VSC) WITH NO SUCCESS. IT WAS NOTED THAT THE CUSTOMER DID NOT HAVE A SECOND 0-DEGREE ENDOSCOPE TO VERIFY THE ENDOSCOPE AND WAS ASKED IF THE CUSTOMER HAD ANY OTHER ENDOSCOPE TO TRY. THE CUSTOMER FOUND A 30-DEGREE ENDOSCOPE WHICH WORKED WITHOUT ERROR. THE TSE RECOMMENDED THE CUSTOMER TRY THE 0-DEGREE ENDOSCOPE AGAIN AND THE ERROR RETURNED. THE CUSTOMER TRIED THE ENDOSCOPES BACK AND FORTH WITH THE SAME RESULT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213363 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-04 N/A 00886874110744

    Patients

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