BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16433977 · Received February 24, 2023

    Report

    Report Number
    2955842-2023-10865
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 25, 2023
    Report Date
    January 25, 2023
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR- RIGHT (MTMR) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT ¿RIGHT FINGER CLUTCH WON¿T RESPOND¿. THE MTM WAS ANALYZED, AND THE REPORTED FAILURE WAS ABLE TO BE REPRODUCED DURING VISUAL INSPECTION. THE OPTO BUTTON ASSEMBLIES WILL BE REPLACED AS A FIX.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A DISABLED FINGER CLUTCH AND NON-INTUITIVE MOVEMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE CONFIRMED THE ISSUE VIA SYSTEM LOGS BUT COULD NOT REPRODUCE THE REPORTED PROBLEM. FSE REPLACED THE RIGHT MASTER TOOL MANIPULATOR (MTM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT REGARDING RIGHT FINGER CLUTCH NOT RESPONDING WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID NOT CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. ISI HAS NOT RECEIVED THE MTM FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: SITE REPORTED THE RIGHT FINGER CLUTCH WOULD NOT RESPOND SO THE SURGEON CONTINUED THE PROCEDURE BY USING THE CLUTCH PEDAL, BUT THIS CAUSED THE SYSTEM TO DO UNEXPECTED MOVEMENTS FROM TIME TO TIME. THE RIGHT MTM WAS REPLACED AFTER COMPLETION OF THE PROCEDURE. 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. UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE AND SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION. AT THIS TIME, THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. 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

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RECTOPEXY SURGICAL PROCEDURE, THERE WAS A MESSAGE INDICATING THAT SYSTEM HAS DISABLED THE RIGHT FINGER CLUTCH. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SPOKE TO THE SURGEON WHO CONFIRMED THE ISSUE, AND INDICATED THAT HE WAS USING THE CLUTCH PEDAL INSTEAD, BUT IT WAS NOT COMFORTABLE. THIS ALSO MADE HIM DO UNEXPECTED MOVEMENTS FROM TIME TO TIME, AS A RESULT OF SYNCHRONIZATION BETWEEN FOOT CLUTCH AND MASTER TOOL MANIPULATORS (MTM) REPOSITIONING. NEVERTHELESS, HE INFORMED THAT HE WOULD CONTINUE WITH THE CASE WITHOUT ANY PROBLEM. SYSTEM LOG FILES WERE UNAVAILABLE FOR REVIEW; HOWEVER, THE TSE ADVISED THEY COULD DISABLE THE FINGER CLUTCH FUNCTION; HOWEVER, THE SURGEON PREFERRED USING AT LEAST THE LEFT ONE, AND THE PEDAL FOR THE RIGHT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ON 03-FEB-2023, ISI FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS PERSISTENT, AND CONTROL REMAINED NON-FUNCTIONAL FROM THE START OF THE SYSTEM. THE PROBLEM OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON'S CONSOLE AN OBSERVED NON-INTUITIVE INSTRUMENT MOVEMENT. MALFUNCTIONING OF THE FINGER-CLUTCH ON THE RIGHT-HAND CONTROL CAUSED UNEXPECTED MOVEMENTS DURING CLUTCH ATTEMPTS. NO INTERNAL INJURIES, NO CONSEQUENCES FOR THE PATIENT. THE SURGEON ADAPTED BY USING THE FOOT CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993909 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-16 N/A 00886874110744

    Patients

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