BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 21257523 · Received January 28, 2025

    Report

    Report Number
    2955842-2025-00797
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 6, 2025
    Report Date
    January 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY A QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 32139 - THIS ERROR IS LOGGED WHEN THE POWER-ON SELF-TEST FOR HIGH-SIDE SWITCHES FAILS. 32145 - THIS ERROR LOGGED DURING THE HIGH SIDE SWITCH POST IF PRIOR OR DURING THE TEST THERE IS AN ACTIVE FRL. 32101 - LOCAL FRL WAS HIT BECAUSE OF A HIGH SIDE SWITCH ERROR. DEVICE HISTORY RECORD (DHR) REVIEW-DHR REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO HIGH SIDE SWITCH. FSE HAVE REPLACED THE MASTER TOOL MANIPULATOR (MTM) LEFT TO RESOLVE THIS ISSUE. THIS ISSUE IS CAPTURED IN THE CLINICAL RISK ANALYSIS,GEN5,SYSTEM,MP (818555-10) REV. R VIA RISK ID G5-SYS-5633.

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION FROM ENGINEERING FOUND THE MANIPULATOR CONTROLLER MASTER BASE DRIVER 1 (MCMBD1) PCA TO BE DEFECTIVE. FROM THIS FINDING, FAILURE ANALYSIS CONCLUDED THAT THE MCMBD1 PCA WAS THE ROOT CAUSE OF THE ISSUE.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE MTM WAS RETURNED FOR FAILURE ANALYSIS (FA) AND THE REPORTED ISSUE WAS REPLICATED. FA VERIFIED THE ERRORS VIA THE ERROR LOGS AND THEN PERFORMED A VISUAL INSPECTION FOR ANY PHYSICAL DAMAGE. THEN, THE USM WAS INSTALLED ON A KNOWN GOOD INTERNAL EFT CONSOLE AND PROGRAMMED TO CUSTOMER LATEST SOFTWARE. THEN THE SYSTEM WAS POWERED UP IN NORMAL MODE IN WHICH THE SYSTEM POWERED UP WITH ERROR 32139. FA VERIFIED ERROR CODE AND FAILURE ON STARTUP. THE PROBABLE ROOT CAUSE WAS ATTRIBUTED TO A HIGH SIDE SWITCH. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LEFT HAND CONTROL WAS NOT WORKING. THE CUSTOMER INFORMED THE SYSTEM HAD A NON-RECOVERABLE FAULT AND THERE WAS A MESSAGE PROMPTING THE CUSTOMER TO RESTART THE SYSTEM OR DISABLE THE LEFT MASTER TOOL MANIPULATOR (MTM) TO CONTINUE. THE SYSTEM LOGS SHOWED ERRORS 32139, 32145, AND 32101 POINTING TO THE LEFT MTM. PRIOR TO CALLING, THE CUSTOMER TRIED POWER CYCLING THE SYSTEM WITH NO CHANGE. THE CUSTOMER CONFIRMED THERE WERE NO OBSTRUCTIONS IMPEDING THE LEFT MTM AT STARTUP AND TRIED MULTIPLE HARD REBOOTS OF THE CONSOLE WITH NO CHANGE. THE CUSTOMER DID NOT HAVE ANOTHER DA VINCI 5 CONSOLE AVAILABLE AND ELECTED TO CONVERT THE CASE TO LAPAROSCOPIC SURGERY. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DA VINCI COORDINATOR CONFIRMED THE INITIALLY REPORTED EVENT DATE. THERE WAS AN ERROR, AND THE STAFF FOLLOWED PROMPTS. THE STAFF STATED THAT THE ISSUE RESOLVED AND CONTINUED WITH START OF CASE. THE SURGEON PLACED TROCARS AND WENT TO SIT AT THE SURGEON CONSOLE. THEY NOTICED THE LEFT ARM WOULD NOT MOVE. THEY CALLED SUPPORT FOR ADDITIONAL TROUBLESHOOTING. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC CHOLECYSTECTOMY. THERE WERE NO ADDITIONAL TROCARS PLACED. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY WITH NO INJURY TO THE PATIENT AND THE PATIENT TOLERATED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549035 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-40 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES