BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 13752794 · Received March 13, 2022

    Report

    Report Number
    2955842-2022-10597
    Event Type
    Malfunction
    Date Received
    March 13, 2022
    Date of Event
    February 11, 2022
    Report Date
    February 11, 2022
    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
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OOL MANIPULATOR (MTM) RIGHT AND REMOTE ARM CONTROLLER BOARD (RAC) 2. THE CAUSE OF THE REPORTED FAILURE WAS DUE TO THE SURGEON SIDE CONSOLE (SSC) ARMREST HARNESS ASSEMBLY ISSUE. THE FSE REPLACED THE CABLE TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE SURGEON SIDE CONSOLE (SSC) ARMREST HARNESS ASSEMBLY WAS RETURNED FOR FURTHER INVESTIGATION; HOWEVER, EVALUATION/INVESTIGATION HAS NOT BEEN COMPLETED. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN EVALUATION IS COMPLETED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS RELATED TO THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. PER THE REVIEW, THE ISSUE OCCURRED DURING A PROSTATECTOMY PROCEDURE ON (B)(6) 2022 USING SYSTEM (B)(4). THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER THE 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 PROCEDURE CHANGE. 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.

    Additional Manufacturer Narrative · 0

    D14 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SURGEON SIDE CONSOLE (SSC) ARMREST HARNESS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE CABLES OF HARNESS PASSED CONTINUITY TEST, HI-POT AND VISUAL INSPECTION. NO REPAIR WAS PERFORMED. NO PROBLEM WAS DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT REPEATED ERRORS 25553, 25595 AND 23 OCCURRED. THE ERRORS COULD NOT BE RECOVERED BY THE CUSTOMER. THE TSE HAD THE CSR POWER CYCLE THE WHOLE SYSTEM WITH EMERGENCY POWER OFF (EPO), BUT THE ISSUE PERSISTED. AFTER, THE TSE HAD THE CSR DISABLE THE ARM WHICH CAUSED THE ERRORS. THE CSR STATED THAT AFTER DISABLING THE ARM AND POWER CYCLING THE SYSTEM, THE SYSTEM WAS RECOVERED. THE MASTER TOOL MANIPULATOR (MTM) RIGHT PROBLEM WAS THE CAUSE OF THE REPORTED ISSUE. THE FIELD SERVICE ENGINEER (FSE) WOULD FOLLOW UP. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. AFTER POWERING ON THE SYSTEM, ERROR 23 AND 30 OCCURRED. THE PROCEDURE COMPLETED AS PLANNED WITH THE SAME DA VINCI SURGICAL SYSTEM. INFORMATION REGARDING RELEVANT TESTING AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    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
    1219230 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES