BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 23539368 · Received November 12, 2025

    Report

    Report Number
    2955842-2025-44858
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 12, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR REPORT # 2955842-2025-44859 FOR MDR SUBMISSION OF THE ADVERSE EVENT/MALFUNCTION RELATED TO THE RECURRENCE OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ARCING TO AN UNSPECIFIED TISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, INADVERTENTLY ARCED TO UNSPECIFIED TISSUE. TO ADDRESS THE ISSUE, A BACKUP MCS INSTRUMENT WAS UTILIZED WITH THE SAME MCS TIP COVER ACCESSORY. HOWEVER, THE SAME ISSUE RECURRED. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND ADVISED THE CUSTOMER TO REPLACE THE MCS TIP COVER ACCESSORY IF PHYSICAL DAMAGE WAS OBSERVED AND FURTHER RECOMMENDED DISCONNECTING THE BIPOLAR CABLE IF THE ISSUE OCCURRED NEAR A BIPOLAR INSTRUMENT, GRIPPING TISSUE. AT THIS TIME, IT IS UNKNOWN HOW THE ISSUE WAS ULTIMATELY RESOLVED, WHETHER THE PATIENT SUSTAINED ANY INJURY, OR IF ADDITIONAL MEDICAL INTERVENTIONS WERE REQUIRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165174 DA VINCI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180 N/A

    Patients

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