BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 21820356 · Received April 10, 2025

    Report

    Report Number
    2955842-2025-14410
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 17, 2025
    Report Date
    March 17, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. HOWEVER, FAILURE ANALYSIS IS IN PROGRESS.

    Additional Manufacturer Narrative · 0

    THE USM CAME IN FOR ERROR 23087. THE ERROR WAS CONFIRMED AND REPLICATED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND TRIGGERED NO ERRORS. THE USM WAS ALSO TESTED ON THE PFPT AND FAILED SINE CYCLE WIT ERROR 23097 ON AXIS 0X7 (DOF8). UPON FURTHER INVESTIGATION, THERE WAS FLUID INTRUSION OR PHYSICAL DAMAGE. REMOTE FE ALSO HOW ALSO SHOWS ERROR 1173 HAVING A NODE OF AC 3F (ACC) AND ERROR 23087 ON DOF 8 POINTING THE HALL SENSOR/ENCODER. THE ISA BOARD AND DOF 8 ROTOR ARE CONSISTENT WITH THE REPORTED EVENT AND IS THE ROOT CAUSE OF THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY ENCOUNTERED A REPEATED RECOVERABLE FAULT 23087 ON THE UNIVERSAL SURGICAL MANIPULATOR (USM)3 AFTER DOCKING AND INSTRUMENT INSTALLATION. THE USER ATTEMPTED TO RECOVER THE FAULT, AND RESEATED THE INSTRUMENT AND STERILE ADAPTER MULTIPLE TIMES BUT THE ISSUE PERSISTED. THE TSE GUIDED THE USER TO PERFORM A POWER CYCLE ON THE SYSTEM AND SUCCESSFULLY RESOLVED THE ISSUE. THE USER CONTINUED WITH THE PROCEDURE USING THE SAME SYSTEM CONFIGURATION AS PLANNED. HOWEVER, THE USER CALLED BACK AND REPORTED THAT THE SAME ERROR REOCCURRED MID-PROCEDURE. THE USER FOLLOWED THE TSE' INSTRUCTIONS TO RECOVER THE ERROR AND TROUBLESHOOT THE SYSTEM, BUT THE ISSUE PERSISTED. THE USER DISABLED THE USM3 AND CONTINUED WITH THE PROCEDURE USING THE REMAINING 3 USMS. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014753 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-48 N/A

    Patients

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