BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24017167 · Received January 9, 2026

    Report

    Report Number
    2955842-2026-00782
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 22, 2025
    Report Date
    February 3, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED, AND THE FINDINGS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED ¿DAMAGED/SEVERED ENERGY CORD¿. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED CONTINUITY TEST. THE INSTRUMENT WAS FOUND TO BE FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING PROCEDURE, THE 8MM FORCE BIPOLAR INSTRUMENT WAS FOUND TO HAVE A DAMAGED/SECERED ENERGY CORD. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE COMPLAINT INVOLVED A DAMAGED INSULATION ON THE CONDUCTOR (BLACK) WIRE, WITH NO OTHER ASSOCIATED FUNCTIONAL FAILURES OBSERVED (NO ABNORMAL MOTION, ARCING, OR ENERGY LOSS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399847 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10250227 0007

    Patients

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