BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23835218 · Received December 17, 2025

    Report

    Report Number
    2955842-2025-48793
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    October 21, 2025
    Report Date
    March 13, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112281
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED COMPLAINT. INTERNAL VISUAL AND EXTERNAL INSPECTION REVEALED NO ABNORMALITIES. THE INSTRUMENT PASSED THE MANUAL ARTICULATIONS TEST. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM, AND IT 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 THE GRIP TEST AND PASSED ENERGY DELIVERY TESTING IN VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT ALSO PASSED THE ELECTRICAL CONTINUITY TEST. THE LOG REVIEWS DID NOT SHOW ANY FAILURES. THE INSTRUMENT WAS FULLY FUNCTIONAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT HAD NO ENERGY OUTPUT. AFTER THE USER INCREASED THE ENERGY SETTING, THERE WAS ONLY A SMALL AMOUNT OF ENERGY OUTPUT. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY. THERE WERE NO REPORTS OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185904 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-17 K10240912 0106 00886874112281

    Patients

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