BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 23697963 · Received December 2, 2025

    Report

    Report Number
    2955842-2025-46388
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 4, 2025
    Report Date
    March 6, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 REPRODUCE THE ERROR AND REPLACED THE PATIENT SIDE MANIPULATOR (PSM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, H2, H3, H6, AND H11. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PATIENT SIDE MANIPULATOR (PSM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PSM WAS ANALYZED AND FOUND TO HAVE AN ERROR. A LOG REVIEW SHOWED MULTIPLE ERRORS INCLUDING INSTRUMENT RECOGNITION ERRORS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, A SMALL AMOUNT OF FLUID INTRUSION COULD BE SEEN. THE UNIT WAS THEN INSTALLED ONTO A TEST SYSTEM WHERE ON STARTUP, THE PSM WAS DETECTING AN INSTRUMENT WHEN ONE WAS NOT INSTALLED. THE INSTRUMENT RECOGNITION ERRORS WERE SEEN IN THE SYSTEM LOGS INDICATING THAT A RADIO FREQUENCY IDENTIFIER (RFID) WAS NOT PRESENT/DETECTED. THE PSM WAS PARTIALLY DISASSEMBLED TO INSPECT THE RFID AND HEAVY AMOUNTS OF FLUID INTRUSION WERE SEEN ALONG THE PRINTED CIRCUIT ASSEMBLY (PCA).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE ERROR ISSUE POINTING TO A PATIENT SIDE MANIPULATOR (PSM). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASSISTED THE CUSTOMER WITH A HARD POWER CYCLE, SYSTEM REBOOT, AND DRAPE REMOVAL, BUT THE SYSTEM CONTINUED TO DISPLAY THE ERROR AT EACH POWER-ON. ADDITIONALLY, THE LED ON THE PSM WAS AMBER. DUE TO THE SYSTEM ISSUE, THE CUSTOMER ELECTED TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY AND TWO ADDITIONAL PORTS WERE ADDED. ALSO, THERE WAS A PROCEDURE DELAY OF 15 MINUTES REPORTED. THE PATIENT REPORTEDLY TOLERATED THE CONVERSION TO TRADITIONAL LAPAROSCOPIC SURGERY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50479 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-50 N/A 00886874114605

    Patients

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