BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 21504798 · Received March 3, 2025

    Report

    Report Number
    2955842-2025-02269
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE PRIMARY FAILURE OF ENERGY RECOGNITION FAILURE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO FAIL THE ENERGY RECOGNITION TEST. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE ENERGY GENERATOR. A TORQUE WRENCH WAS USED TO TIGHTEN THE ASSEMBLY UNTIL IT WAS AS TIGHT AS IT COULD BE (CLICKING SOUNDS). THE INSTRUMENT FAILED THE ENERGY RECOGNITION TEST: THE INSTRUMENT GENERATED THE MESSAGE "TIGHTEN ASSEMBLY" ON 3 OUT OF 3 ATTEMPTS. ONE OF THE BLADE EDGES WAS INDENTED, WHICH PREVENTS THE BLADES FROM CLOSING AND CAUSE ENERGY RECOGNITION FAILURES. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THE EVENT INVESTIGATION IS IN PROGRESS.

    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 PROCEDURE, THE HARMONIC ACE INSTRUMENT FAILED TO SEAL 3 SHORT GASTRIC ARTERIES, LEADING TO A BLOOD LOSS OF 650ML AND THE CONVERSION OF THE PROCEDURE TO OPEN. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696020 DA VINCI HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-10 L80240701 0228 10886874112738

    Patients

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