BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21830685 · Received April 11, 2025

    Report

    Report Number
    2955842-2025-14677
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 19, 2025
    Report Date
    March 19, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR 4 (USM4) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND IN REMOTE FE, THE 23008, P1=1 ERROR WAS FOUND INDICATING POT TO ENCODER ERROR FAULT ON THE AXIS 1, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE USM ARM WAS DISABLE DUE TO ERROR 23008. THE UNIT WAS THEN INSTALLED ONTO A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED ADAPTIVE GAIN CONTROL (AGC), CURRENT FOR YAW SEARCHLIGHT PRINTED CIRCUIT ASSEMBLY (PCA), SENSOR CHECK FOR YAW WIGGLE AND SINE CYCLE DUE TO ERROR 23008, P1=1 ON YAW. DURING TESTING, THE YAW SEARCHLIGHT ASSEMBLY WITH PCA WAS APPLIED BEHAVIOR ANALYSIS (ABA) TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE REMOTEFE PROCEDURE LOG SHOWS THE CUSTOMER PERFORMED PROSTATECTOMY - RADICAL W/O LYMPHADENECTOMY PROCEDURE ON (B)(6) 2025 WITH DR. (B)(6) ON SYSTEM (B)(6). A REVIEW OF THE SITE¿S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY RPMS QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 23 INDICATING WHEEL HARDWARE FAULT: MSC REPORTED A HARDWARE FAULT IN THE WHEEL COMMUNICATION. POINTING TO REAR CORE FIBER PORT (TOP PORT); 25724 INDICATING UCE DSPNET ERROR ON MCEL IN RAC1 IN SSC1. A FOLLOWING WHEEL TRANSMIT ROUTINE HAS FAILED; 40084 INDICATING A COMM LINK FROM THE MSC IN ICC IS DOWN. MESSAGE DESTINATION WAS PCC3 IN UCC AND 40 INDICATING GBIT HARDWARE FAULT: THE MSC NODE ON ICC REPORTED A GBIT COMMUNICATION ERROR ON GBIT INSTANCE 0 (CORE: TOP BLUE FIBER PORT, MASTER, LEFT VIDEO AND COMM). DEVICE HISTORY RECORD (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. FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE YAW SEARCHLIGHT ASSEMBLY WITH PCA WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    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 UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE SYSTEM WAS PROGRAMMED, CALIBRATED AND VERIFIED FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    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 SURGICAL PROSTATECTOMY RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) WHILE SETTING UP FOR A PROCEDURE THE SYSTEM HAD RECOVERABLE ERRORS THAT WOULD NOT CLEAR AFTER THE SYSTEM WAS DRAPED. THE CUSTOMER SWAPPED THE PATIENT SIDE CART (PSC) WITH ANOTHER PSC AND WAS PROCEEDED WITH THE PROCEDURE AS PLANNED. THE CUSTOMER HAD MOVED THE PSC FROM THE OR AND REQUESTED A FIELD SERVICE ENGINEER TO FOLLOW UP. THE TSE REVIEWED THE SYSTEM LOGS AND CONFIRMED MULTIPLE COMMUNICATION ERRORS IN THE SYSTEM LOGS. THE PROCEDURE WAS ABORTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE NURSE ASKED TO CLARIFY THE ARM NEEDED TO BE REPLACED, SO WE DIDN¿T HAVE ENOUGH SYSTEMS FOR THE FOLLOWING DAY. AS A RESULT, ONE OF THE CASES WAS CONVERTED TO A LAPAROSCOPIC PROCEDURE. THE NURSE INFORMED IT WASN'T THE SECOND ISSUE. THE SYSTEM WAS UNAVAILABLE FOR A CASE ON 3/20. THE CASE WAS SCHEDULED FOR NOON, BUT THE SYSTEM WAS UNDER REPAIR AND NOT ACCESSIBLE AT THAT TIME. SINCE THE SYSTEM WASN'T AVAILABLE, THEY REACHED OUT TO THE SURGEON. THEY DECIDED NOT TO WAIT FOR THE SYSTEM AND CONVERTED HER CASE TO A LAPAROSCOPIC PROCEDURE THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989255 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A

    Patients

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