BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 22909340 · Received August 27, 2025

    Report

    Report Number
    2955842-2025-35797
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 1, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE SYNCROSEAL INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    ON 08/01/2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: SURGEON SAW THE PROTECTIVE WHITE COATING OF SYNCROSEAL DEVICE BECOME SEPARATED FROM INSTRUMENT. IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA SURGICAL PROCEDURE, SURGEON SAW THE PROTECTIVE WHITE COATING OF SYNCROSEAL DEVICE BECOME SEPARATED FROM INSTRUMENT. THE PROCEDURE WAS UNKNOWN WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251034 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 K10250514 10886874117306

    Patients

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