BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24202666 · Received January 28, 2026

    Report

    Report Number
    2955842-2026-02483
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 2, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND PHONE SUPPORT DETAILS. THE INVESTIGATION DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER AND CONFIRMED THEY WERE CALLING FOR HELP MORE THAN WANTING A FSE TO COME ON SITE. FSE SUGGESTED THAT SHE CALL HER SALES LEADS FOR HELP WITH INSTRUMENT AND ACCESSORY QUESTIONS. THE FSE ALSO NOTED THAT IT COULD BE A USER-RELATED ISSUE. 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT WAS RUNNING INTO SOMETHING DURING A GUIDED TOOL CHANGE RE-ENTRY. THE OPERATING ROOM STAFF CALLED IN TO REPORT THAT THE TISSUE OR LIVER WAS BEING HELD UP BY A STITCH AND WAS ALSO PARTIALLY RESTING ON THE INSTRUMENT SHAFT OF THE INSTRUMENT ON ARM 1. WHEN THE INSTRUMENT ON ARM 1 WAS REMOVED, THE TISSUE DROPPED DOWN SLIGHTLY BECAUSE IT WAS NO LONGER RESTING ON THE SHAFT DURING THE INSTRUMENT EXCHANGE. UPON RE-INSERTING THE NEW INSTRUMENT, IT RAN INTO THE TISSUE OR LIVER BECAUSE IT HAD DROPPED INTO THE PATH OF THE INSTRUMENT BEING RE-INSERTED. ALTHOUGH THE WHITE LINE ON THE SCREEN INDICATED A CLEAR PATH FOR THE INSTRUMENT BEING RE-INSERTED ONTO ARM 1, THIS WAS NOT THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A GASTRIC BYPASS. THERE WAS NO HARM OR INJURY TO THE PATIENT. IT HAPPENED THREE TIMES, ADDING ABOUT ONE MINUTE A PIECE. AFTER THE THIRD INCIDENT, THE SURGEON AND HER FA DIDN'T USE GUIDED TOOL CHANGE AND INSERTED EACH INSTRUMENT UNDER DIRECT SUPERVISION WHICH ADDED ADDITIONAL MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266154 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-40 N/A 00886874119716

    Patients

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