BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 24616015 · Received March 17, 2026

    Report

    Report Number
    2955842-2026-16406
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 20, 2026
    Report Date
    April 20, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THE FSE RECONFIGURED THE CENTRAL CONFIGURATION MANAGEMENT (CCM) BLOB FROM VERSION 4 TO VERSION 12. FSE STATED NO ISSUES OR ERRORS EXPERIENCED AFTER SYSTEM START-UP. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A REVIEW OF THE SITE'S SYSTEM LOGS WAS PERFORMED, AND THE INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED ERRORS: NON-RECOVERABLE SOFT LOCK (NSL): FEATURE HEALTH MONITOR INDICATES A GIVEN FEATURE IS IN AN INVALID STATE. (APPID: UI AGGREGATOR APP; SUPPORTED NODEID: FHD PATIENT CART CONTROLLER (PCC) #3 ID; FEATURED: ALIVE). RECOVERABLE EMERGENCY STOP (RES): AURORA LINK ERROR. (REPORTER: COMMON COMPUTE CONTROLLER (CCC), TOWER), (LINK TO TOWER'S BLUE FIBER PORT #3). PHYSICAL MEDIUM ACCESS (PMA): N/A REPORTED CCM ERROR: USING DEFAULT VALUE. (REASON: INTEGRATED TABLE ENABLED).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2, H3, H6, H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER PORT PLACEMENT AND PRIOR TO STARTING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE CUSTOMER STATED THE SYSTEM WAS ALERTING THAT THE SURGEON SIDE CONSOLE (SSC) WAS NOT CONNECTED. THE CUSTOMER OBSERVED A SYSTEM ALERT INDICATING THAT THE SURGEON SIDE CONSOLE (SSC) WAS NOT CONNECTED. INITIAL TROUBLESHOOTING BY THE CUSTOMER INCLUDED POWER CYCLING THE SYSTEM AND RESEATING THE FIBER CABLES; HOWEVER, THE ISSUE PERSISTED. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND, AFTER REVIEWING THE SYSTEM LOGS, CONFIRMED THE ISSUE. THE TSE GUIDED THE CUSTOMER THROUGH ADDITIONAL TROUBLESHOOTING STEPS: POWER CYCLING THE SYSTEM AGAIN AND REPLACING THE FIBER CABLE BETWEEN THE SSC AND THE VISION SIDE CONSOLE (VSC). FOLLOWING THESE ACTIONS, THE SYSTEM SUCCESSFULLY RECOGNIZED THE SSC. HOWEVER, THE INTEGRATED TABLE MOTION (ITM) THEN DID NOT FUNCTION AS EXPECTED. THE TSE IDENTIFIED A RELATED ERROR IN THE SYSTEM LOGS BUT OPTED NOT TO INTERVENE REMOTELY DUE TO THE ONGOING PROCEDURE. THE CUSTOMER REPORTED THAT THE SURGEON HAD ALREADY DECIDED TO CONVERT TO AN OPEN PROCEDURE EARLY IN THE TROUBLESHOOTING PROCESS AND INDICATED THEY WOULD CALL BACK TO FURTHER ADDRESS THE ITM ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57893 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45 N/A 00886874119747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES