BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 15633879 · Received October 19, 2022

    Report

    Report Number
    2955842-2022-14687
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 19, 2022
    Report Date
    September 19, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115374
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE REPRODUCED THE REPORTED ISSUE AND REPLACED THE MASTER TOOL MANIPULATOR-LEFT (MTML) . THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE PART FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A PROCEDURE LOG REVIEW CONFIRMED THE PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2022 ON SYSTEM (B)(4). NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER HAD DIFFICULTIES OPENING THE JAWS OF THE INSTRUMENT WITH THE LEFT MASTER TOOL MANIPULATOR (MTML). 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MASTER TOOL MANIPULATOR (MTM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS ABLE TO REPRODUCE THE REPORTED ISSUE DURING VISUAL INSPECTION. DURING EVALUATION, THE INNER AND OUTER GRIP SPRINGS WERE FOUND TO BE DAMAGED, AND THE GRIP LEVERS COULD NOT BE OPENED PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, SURGEON WAS FACING ISSUE WITH MASTER TOOL MANIPULATOR-LEFT (MTML). CALLER STATED THAT HE HAD DIFFICULTIES WITH LEFT MANIPULATOR TO OPEN JAWS OF A BIPOLAR FORCEPS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR(USM)1. CALLER STATED THAT THEY TRIED TO INSTALL A NEW INSTRUMENT WITHOUT ANY SUCCESS. TSE ASKED HIM TO REMOVE THE INSTRUMENT AND RESEAT THE STERILE ADAPTER, NO CHANGE. TSE VIEWED THE SYSTEM EVENT LOGS BUT COULD NOT SEE ANY RELEVANT ERROR CODE. TSE ASKED THEM IF THEY CAN REPLACE THE DRAPE. NURSE WILL CALL BACK IF THEY HAVE THE OPPORTUNITY TO DO IT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOT WAS STARTED UP NORMALLY WITHOUT ANY INITIALIZATION PROBLEM OR FAULTY SIGNAL. FROM THE BEGINNING OF ITS USE THE LEFT JOYSTICK HAD A RESISTANCE TO OPEN ITS JAWS AND THEREFORE A DIFFICULTY TO OPEN THE PROGRASP WHICH WAS HOWEVER FUNCTIONAL, THE CHANGE OF INSTRUMENT COULD NOT ALLOW TO CORRECT THIS.

    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
    2939057 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-12 N/A 00886874115374

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.