BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 21684465 · Received March 24, 2025

    Report

    Report Number
    2955842-2025-10189
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    February 24, 2025
    Report Date
    February 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND UPON VISUAL INSPECTION, THE ROLLING LOOP FIBER ASSEMBLY WAS FOUND DAMAGED. THE USM WAS INSTALLED ONTO A TEST SYSTEM AND THE SAME ERROR FROM THE REPORTED EVENT INDICATING FAULT ON THE USM, WAS TRIGGERED. THE USM WAS THEN INSTALLED ONTO A ANOTHER TEST SYSTEM THE ERROR WAS PRESENT ON THE AXES CONTROLLER CARRIAGE (ACC) PRINTED CIRCUIT ASSEMBLY (PCA). THE ROLLING LOOP FIBER WAS VERIFIED TO BE THE SOURCE OF THE FAULT. ADDITIONAL INFORMATION: A REVIEW OF THE SITE¿S SYSTEM LOGS WAS PERFORMED WHICH CONFIRMED THE CUSTOMER REPORTED REPEATED ERROR ON USM #2.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE WAS ABLE TO REPRODUCE THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 ERROR AND THEREFORE THE USM WAS REPLACED. THE USM HAS BEEN RETURNED TO ISI FOR FAILURE ANALYSIS, WHICH HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION, THE CUSTOMER EXPERIENCED A REPEATED RECOVERABLE ERROR POINTING TO UNIVERSAL SURGICAL MANIPULATOR (USM) #2. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER POWER-CYCLED THE SYSTEM TWICE TO NO AVAIL. THE TSE THEN ADVISED THE CUSTOMER TO PERFORM A HARD POWER-CYCLE, BUT THIS DID NOT RESOLVE THE ISSUE. THE SURGEON ELECTED TO ABORT THE PROCEDURE AT THE TIME OF THE USM ISSUE DUE TO THE PATIENT'S INSTABILITY WHICH WAS ANATOMY RELATED. HOWEVER, SPECIFIC DETAILS REGARDING THE PATIENT'S INSTABILITY ISSUE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100314 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-38 N/A 00886874115404

    Patients

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