BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 24946071 · Received April 21, 2026

    Report

    Report Number
    2955842-2026-22425
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 21, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    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. FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM1) DUE TO ERROR 32056. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS NOT RECEIVED THE USM1 FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED. THE PROBABLE CAUSE OF ERROR 32056 POINTS TO AXES CONTROLLER, ARM (ACA) IN USM1 FAILED TO INITIALIZE I2C DEVICE:

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM WAS HAVING A REPEATED ERROR 32056 ON UNIVERSAL SURGICAL MANIPULATOR (USM1). BEFORE CALLING TECHNICAL SUPPORT ENGINEER (TSE), THEY HAD ALREADY POWER CYCLED THE SYSTEM TWICE WITHOUT SUCCESS. THEY WERE ABOUT TO DOCK THE ROBOT TO THE PATIENT. TSE REVIEWED ERROR LOGS AND CONFIRMED ERROR 32056 POINTING TO USM 1 AXES CONTROLLER, ARM (ACA) BOARD. TSE ASKED CUSTOMER WHETHER THEY COULD PERFORM THE PROCEDURE WITH THREE USMS AND THEY STATED IT WAS NOT THE CASE. TSE GUIDED CUSTOMER TO POWER THE SYSTEM OFF PERFORMING AN EMERGENCY POWER OFF (EPO) ON PATIENT SIDE CART (PSC) WITHOUT SUCCESS. THE SURGEON DID NOT KNOW FOR SURE HOW THEY WERE GOING TO PROCEED WITH THE PATIENT BUT STATED THEY WERE MOST LIKELY GOING TO CONVERT TO LAPAROSCOPIC SURGERY. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY WITH NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111149 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-46 N/A 00886874115404

    Patients

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