BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI 5

    MDR report key: 24534396 · Received March 6, 2026

    Report

    Report Number
    2955842-2026-10592
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE SPOKE WITH THE ROBOTICS COORDINATOR WHO INFORMED THEY WOULD BE SWAPPING THE TOWER WITH THE ALLEGED SYSTEM WITH THE TOWER FROM ANOTHER SYSTEM BETWEEN CASES TO SEE IF THE ISSUE FOLLOWED IN ORDER TO DETERMINE IF THE ISSUE WAS WITH THE INSUFFLATOR OR THEIR HOUSE GAS SYSTEM. LATER ON, THE FSE REPLACED THE INSUFFLATOR DUE TO PRESSURE DROP REPORTEDLY OCCURRING IN TWO CASES. NO ERROR CODES WERE NOTED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INSUFFLATOR WAS ANALYZED AND THE REPORTED ISSUE WAS CONFIRMED AND REPLICATED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE INSUFFLATOR WAS INSTALLED ONTO THE KNOWN GOOD IN-HOUSE SYSTEM AND POWERED ON WITH INSUFFLATOR DISABLED. FROM THESE FINDINGS, FAILURE ANALYSIS COULD NOT DETERMINE THE ROOT CAUSE OF THE ISSUE. THE UNIT WILL BE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR POTENTIAL REPAIR. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN ISSUE WITH THE INSUFFLATION. THEY STATED THAT THE READINGS ON THE INSUFFLATOR WERE ALL SET TO NORMAL PRESSURE AND INSUFFLATION WAS GOOD. THEN, ALL OF A SUDDEN, THE INSUFFLATION WOULD STOP AND ALL GO TO ZERO SETTINGS ON THE INSUFFLATOR, AND THEY WOULD TEMPORARILY LOSE INSUFFLATION. WITHOUT DOING ANYTHING, THE INSUFFLATOR WOULD CORRECT ITSELF AND ALL THE ORIGINAL SETTINGS WOULD BE SEEN, AND INSUFFLATION WAS BACK TO NORMAL. THEY STATED THEY CHECKED THE INCOMING GAS PRESSURE AND HAD NO DROPS IN PRESSURE. NO STAFF MEMBERS TOUCHED THE INSUFFLATOR. THEY ALSO STATED THAT THE SYSTEM GAVE NO WARNINGS OR FAULTS WHEN THE ISSUE OCCURRED. THEY STATED IT WAS VERY RANDOM. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350286 DA VINCI 5 INSUFFLATOR AND TUBE SET WITH SMOKE EVACUATION NAY INTUITIVE SURGICAL, INC 373750-20 N/A

    Patients

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