BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24854715 · Received April 13, 2026

    Report

    Report Number
    2955842-2026-21310
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    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 EVENT. THE FSE REPLACED THE PATIENT SIDE CART (PSC) COMMON COMPUTER CONTROLLER (CCC)TO CORRECT THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER CONFIRMED THAT THIS WAS JUST A DRAPE ISSUE. THE DRAPE WAS GETTING CAUGHT, CAUSING THE SURGEON TO LOSE SOME REACH. THE CUSTOMER CAUGHT IT AND CORRECTED IT. THE PATIENT SIDE CART (PSC) COMMON COMPUTER CONTROLLER (CCC) HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM AND THE REPORTED ERRORS 31089, 170, 307 WERE CONFIRMED BUT NOT REPLICATED. IN VIA LIGHTHOUSE REVIEW LOGS, ERRORS 31089, 170, 307 WERE FOUND CONFIRMING THAT THE FAULT HAD OCCURRED IN THE FIELD. ADDITIONALLY, THE SYSTEM WAS UNABLE TO PROGRAM THE PCC-PIC IC DURING THE PROGRAMMING PROCESS. THIS ISSUE WAS DETERMINED TO BE CAUSED BY A FAULTY PCC-PIC IC. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE VISION SIDE CART (VSC) CCC WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. DURING ADDITIONAL TESTING, FIBER OPTIC LIGHT LEVELS ON THE PSC CCC WERE MEASURED WITH ALL VALUES FOUND TO BE WITHIN THE EXPECTED RANGE. AFTER THIS INSPECTION, TEN POWER CYCLES WERE COMPLETED WITHOUT INCIDENT. THE CCC WAS THEN LEFT IDLE IN THE GOLDEN SYSTEM FOR 72 HOURS, DURING WHICH NO ABNORMALITIES WERE OBSERVED. BASED ON THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT NO ROOT CAUSE COULD BE IDENTIFIED FOR THE REPORTED EVENTS. ADDITIONALLY, AFTER THE TEST WAS COMPLETED THE ERROR LOG SHOWED THE PCC_PIC NODE WAS MISSING. THEN THE SYSTEM WAS REBOOTED FOR THE PURPOSE OF REPROGRAMMING THE PIC WAS UNSUCCESSFUL. THIS ISSUE WAS DETERMINED TO BE CAUSED BY A FAULTY PCC-PIC IC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT AN ISSUE WAS ENCOUNTERED BY THE OPERATION ROOM STAFF INVOLVING FAULTS ON ARMS 1 AND 3. TROUBLESHOOTING BEGAN WHEN THE SYSTEM WAS POWER CYCLED, WHICH RESOLVED THE ERRORS AT THAT TIME. THE LOGS AVAILABLE DURING THE TROUBLESHOOTING WERE LIMITED, AND ONLY 31004 ERRORS COULD BE CONFIRMED. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604763 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-42 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1