BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22135465 · Received June 3, 2025

    Report

    Report Number
    2955842-2025-23486
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 7, 2025
    Report Date
    May 7, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE FOUND THAT THE SURGICAL DRAPE APPEARED TO BE APPLIED TOO TIGHTLY AROUND THE PATIENT SIDE CART (PSC). WHEN THE PSC¿S MOMENTUM STOPPED DURING POSITIONING, THE TENSION FROM THE DRAPE LIKELY TRANSMITTED A PULLING FORCE TO THE UNIVERSAL SURGICAL MANIPULATOR (USM). ADDITIONALLY, THE OPERATING ROOM FLOOR WAS NOTED TO BE UNEVEN, POTENTIALLY CONTRIBUTING TO INSTABILITY DURING MOVEMENT OF THE PSC. THE FSE CONDUCTED AN USM ADVANCE BRAKE TEST AND A TEST DRIVE WITH NO PROBLEMS IDENTIFIED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION THE PROBABLE ROOT CAUSE MAY BE ATTRIBUTED TO A MECHANICAL INTERFERENCE DUE TO EXCESSIVE DRAPE TENSION, COMPOUNDED BY ENVIRONMENTAL FACTORS (UNEVEN FLOORING), RESULTING IN UNINTENDED FORCE TRANSMISSION TO THE USM DURING PSC MOVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED ISI TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WAS DRIFTING WHILE DOCKED IN THE PATIENT. TSE REVIEWED LOGS AND FOUND NO ASSOCIATED FAULTS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: AFTER ADDITIONAL INQUIRY INTO THE ISSUE. I HAVE FOUND THAT ARM 4 HAD A DRIFT BASED ON INFORMATION FROM THE BEDSIDE FA. ARM MAY NOT HAVE BEEN COMPLETELY DOCKED OR PARTIALLY DOCKED WHICH ALLOWED ARM MOVEMENT. UNSURE IF THE ARM WAS SNUG AGAINST THE CANNULA. INSERVICE PROVIDED WITH FA ON DOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889526 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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