BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 25238072 · Received May 21, 2026

    Report

    Report Number
    2955842-2026-25886
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    October 14, 2025
    Report Date
    May 20, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114315
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 6MM MONOPOLAR CAUTERY INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A RECOGNITION FAILURE BASED ON LOG REVIEW BUT WAS NOT REPLICATED DURING IN-HOUSE TESTING. A REVIEW OF LOGS SHOWED 1 NUMBER OF 31009 ERROR CODES, INDICATING INSTRUMENT SENSORS MISSING. A TOOL WAS PARTIALLY DETECTED ON PATIENT SIDE MANIPULATOR (PSM)1, ONE OR MORE OF THE TOOL SENSORS WERE NOT DETECTED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT WAS RETESTED AND PASSED RECOGNITION AND ENGAGEMENT ON BOTH ATTEMPTS. THE HOUSING WAS REMOVED FOR INSPECTION, AND THE INSTRUMENT DID NOT EXHIBIT ANY INTERNAL PHYSICAL DAMAGE. FA FOUND ADDITIONAL OBSERVATIONS THAT ARE RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A BROKEN INSTRUMENT TUBE ADAPTER. THIS COMPONENT IS LOCATED AT THE DISTAL END OF THE INSTRUMENT AND SERVES AS THE INTERFACE BETWEEN THE INSTRUMENT AND THE USER INSTALLED TIP ACCESSORY. THE BROKEN PIECE WAS NOT RETURNED AND MEASURED APPROXIMATELY 2.26 X 3.35 MM IN SIZE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN ELECTRICAL CONTACT. BOTH SIDES OF THE ELECTRICAL CONTACT WERE FOUND BROKEN IN THE OVER MOLDED SEAL ADAPTER LOCATION. BOTH PIECES, MEASURING ROUGHLY .90 MM X 3.72 MM (X2) IN SIZE WERE NOT RETURNED WITH THE INSTRUMENT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF RECOGNITION FAILURE IS ATTRIBUTED TO COMMUNICATION ISSUES WITH THE RFID CHIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE 6MM MONOPOLAR CAUTERY INSTRUMENT WOULD NOT RECOGNIZE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT NO FRAGMENTS FELL INTO THE PATIENT AND THERE WERE NO REPORTS OF FRAGMENTS DETACHING FROM THE DEVICE WHILE USED WITHIN THE PATIENT. NO ACTIONS RELATED TO FRAGMENT RETRIEVAL WERE REQUIRED. NO POST-SURGICAL COMPLICATIONS OR HOSPITAL RETURNS ASSOCIATED WITH RETAINED FOREIGN MATERIAL WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314303 ENDOWRIST SP MONOPOLAR CAUTERY INSTRUMENT NAY INTUITIVE SURGICAL, INC 430007-62 K10250508 0011 00886874114315

    Patients

    Seq Age Sex Outcome Treatment
    1