BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21822974 · Received April 11, 2025

    Report

    Report Number
    2955842-2025-14449
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 21, 2025
    Report Date
    March 21, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS ATTRIBUTED TO THE USER, AS DVI WAS NOT PROPERLY CONNECTED. THE CABLES INTENDED TO BE USED WERE NOT THE SPECIFIED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE ISSUE WAS RESOLVED BY THE OPERATING ROOM (OR) STAFF CONTACTING THE COORDINATOR AND GUIDING TO FIND CORRECT CABLES TO RESTORE STRYKER TOWER CONNECTION. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THE VIDEO OUTPUT TO STRYKER BOOM STARE WASN¿T WORKING. THE SURGEON CONVERTED TO LAP BEFORE CALLING. THE CUSTOMER STATED THE SYSTEM WAS MOVED OUT OF THE ROOM SO FLOORS COULD BE CLEANED. WHEN THE SYSTEM WAS MOVED BACK IN, THE ONLY DIGITAL VIDEO INTERFACE CABLE THEY COULD FIND DID NOT CONNECT ONTO THE PORT IN VISION SIDE CART. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: FOLLOW-UP ATTEMPT #: ON 3/27/2025, THE DAVINCI COORDINATOR (B)(6) DOES NOT HAVE ANY INFORMATION OR FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350165 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-45 N/A

    Patients

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