BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18309959 · Received December 12, 2023

    Report

    Report Number
    2955842-2023-21179
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 15, 2023
    Report Date
    November 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A SITE VISIT AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS REPLACED TO RESOLVE THE ISSUE. ISI DID RECEIVE THE DA VINCI PRODUCT, BUT THE FAILURE ANALYSIS EVALUATION HAS NOT YET BEEN COMPLETED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR ASSOCIATED WITH THIS COMPLAINT. FAILURE ANALYSIS CONFIRMED THE REPORTED EVENT VIA THE COMPLAINT DETAILS, BUT IT WAS NOT REPLICATED IN-HOUSE. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE THERE WERE NO TRIGGERED ERRORS. THE UNIT WAS ALSO TESTED WHERE THE FRICTION VERY SLOW TEST FAILED FOR THE PITCH. REMOTE LOGS REVIEW SHOWED A 31086-ERROR POINTING TO A FAILURE TO COMMUNICATE. UPON PHYSICAL INSPECTION, THERE WERE NO SIGNS OF PHYSICAL DAMAGE OR FLUID INTRUSION PRESENT IN THE CARRIAGE OR SPAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT ATTACHED TO ARM 3 MOVED UNINTUITIVELY. THE PCH BLUNTLY MOVED INTO THE LIVER, NO INJURY OCCURRED, NO BLEEDING FROM THE EVENT, AND NO INTERVENTION WAS REQUIRED. AFTER THE BEDSIDE ASSISTANT SUCCESSFULLY PUSHED THE INSTRUMENT THROUGH THE TROCAR INTO THE PATIENT THE SURGEON THEN ATTEMPTED TO MOVE THE PCH TO THE INTENDED LOCATION. WHILE THE SURGEON ATTEMPTED TO MOVE THE INSTRUMENT WITH THE CONTROLS IS WHEN THE INSTRUMENT STARTED MOVING IN AN UNINTENDED DIRECTION, THE SURGEON COULD NOT REGAIN CONTROL WITH THE MASTER TOOL MANIPULATOR (MTM). THE INSTRUMENT DID NOT STOP MOVING UNTIL IT "BUMPED" INTO THE LIVER. AFTER THE INSTRUMENT STOPPED MOVING UNINTUITIVELY, THE SURGEON WAS THEN ABLE TO REGAIN CONTROL AND CONTINUED TO USE THE PCH AS INTENDED WITH NO FURTHER ISSUES FOR THE REMAINDER OF THE PROCEDURES. NO SYSTEM ERRORS OR INSTRUMENT ERRORS OCCURRED DURING THE EVENT, THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE SURGEON CONFIRMS THAT THEIR HEAD WAS ENGAGED IN THE CONSOLE AND THEIR HANDS WERE ON THE MTM AT THE TIME OF THE EVENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384702 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A 00886874110720

    Patients

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