BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI ENERGY

    MDR report key: 23659075 · Received November 26, 2025

    Report

    Report Number
    2955842-2025-46212
    Event Type
    Injury
    Date Received
    November 26, 2025
    Report Date
    March 4, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: H2 AND H11. ADDITIONAL INFORMATION: ADDITIONAL REVIEW OF THE CUSTOMER PROVIDED IMAGES SHOWS THAT IN THE FIRST IMAGE, THE SYNCHROSEAL INSTRUMENT IS SHOWN GRASPING TISSUE. IN THE SECOND IMAGE, TISSUE IS VISIBLE WITH CHARRING THAT MATCHES THE SHAPE OF THE INSTRUMENT JAWS; HOWEVER, THE TISSUE DOES NOT APPEAR TO BE TRANSECTED. WHEN THE BLUE PEDAL IS PRESSED, SYNCHROSEAL WILL SEAL OR SPOT COAGULATE THE TISSUE. PRESSING THE YELLOW PEDAL ACTIVATES THE SYNC FUNCTION, WHICH BOTH SEALS AND TRANSECTS. UNFORTUNATELY, THE PROVIDED IMAGES DO NOT INDICATE WHICH PEDAL THE SURGEON PRESSED, SO IT IS NOT POSSIBLE TO DETERMINE WHETHER THE INSTRUMENT FAILED TO CUT.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: H2, H6, H11. ADDITIONAL INFORMATION: THE ISSUE OCCURRED WHILE IN SYNC MODE, AND RESULTED IN CHARRED TISSUE THAT WAS NOT SEPARATED. A REVIEW OF AN IMAGES PROVIDED BY THE CUSTOMER SHOWS THAT THERE IS NO OBVIOUS DAMAGE TO THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. INSUFFICIENT INFORMATION IS AVAILABLE FOR PROCEDURE VERIFICATION; THEREFORE, NO DA VINCI SYSTEM OR INSTRUMENT LOGS ARE AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED NUMBER OF DA VINCI-ASSISTED PROCEDURES, THE SYNCHROSEAL INSTRUMENT WOULD NOT ADEQUATELY CUT TISSUE AND INSTEAD ¿CHEWED¿ THE TISSUE. IN INCIDENTS WHERE THE SYNCHROSEAL INSTRUMENT DID SUCCESSFULLY CUT TISSUE, THIS WAS ONLY ACHIEVED BY APPLYING MAXIMUM TRACTION-COUNTERTRACTION. AS A RESULT, THE PARTIALLY UNCUT TISSUE WOULD TEAR CAUSING MINIMAL BLEEDING; HOWEVER, NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED TO MANAGE THE TISSUE DAMAGE OR BLEEDING. AT NO TIME WAS TISSUE CUT WITHOUT BEING FULLY SEALED, AND NO ADDITIONAL TISSUE REMOVAL WAS NECESSARY. THE FOLLOWING INFORMATION IS UNKNOWN: THE PROCEDURE TYPES, WHAT TISSUE OR VESSEL WAS SPECIFICALLY INJURED, SPECIFIC AMOUNT OF BLEEDING, OR HOW THE PROCEDURES WERE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569929 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 N/A

    Patients

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