BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 23111187 · Received September 22, 2025

    Report

    Report Number
    2955842-2025-38282
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 26, 2025
    Report Date
    August 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE AND REPLACED A WHEEL ASSEMBLY AND RIGHT MOTOR DRIVE ASSEMBLY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PARTS INVOLVED WITH THIS COMPLAINT ARE FIELD SCRAP ITEMS AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE CUSTOMER ENCOUNTERED A REPEATED NON-RECOVERABLE FAULT ERROR. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE OPERATING ROOM (OR) TEAM REMOVED THE INSTRUMENTS FROM THE PATIENT SIDE CART (PSC), UNDOCKED THE ARMS FROM THE PATIENT, AND ATTEMPTED 2 SYSTEM RESTARTS UNSUCCESSFULLY. THE TSE REVIEWED THE LOGS AND FOUND AN ERROR POINTING TO THE RIGHT CART DRIVE WHEEL BRAKE CURRENT. THE TSE GUIDED THE CUSTOMER THROUGH ONE ADDITIONAL SYSTEM SHUTDOWN WITH EMERGENCY POWER OFF (EPO) ON THE PSC. HOWEVER, THERE WAS NO CHANGE TO THE FAULT CONDITION, AND THERE WAS NO OPTION TO RECOVER OR DISABLE. THE OR TEAM INDICATED THAT THE PROCEDURE WOULD BE ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169334 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-41 N/A

    Patients

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