BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25051439 · Received April 30, 2026

    Report

    Report Number
    2955842-2026-23492
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    October 22, 2025
    Report Date
    April 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, INDICATING AN INTERRUPTED ELECTRICAL PATHWAY BETWEEN THE INSTRUMENT PINS AND GRIP TIPS. THE CONTINUITY TEST WAS PERFORMED ON EACH GRIP AND CURRENT FLOW WAS NOT DETECTED ACROSS EITHER GRIP TIP. THERE IS NOT OBVIOUS DAMAGE TO THE CONDUCTOR WIRE(S). DURING FAILURE ANALYSIS, INSTRUMENT FAILED CONTINUITY TEST BUT PASSED ENERGY DELIVERY TEST. FOLLOWING ENERGY DELIVERY TEST, A BURNT SMELL WAS DETECTED FROM THE INSTRUMENT HOUSING. ADVANCED FAILURE ANALYSIS WAS PERFORMED AND THE INITIAL FINDINGS WERE PARTIALLY CONFIRMED. THE INSTRUMENT PASSES ENERGY RECOGNITION, HOWEVER FAILS TO DELIVER ENERGY INTERMITTENTLY. THE INSTRUMENT FAILED CONTINUITY TEST INTERMITTENTLY FOR ONE OF THE GRIPS. AT CERTAIN JAW ORIENTATIONS, ENERGY DELIVERY AND CONTINUITY WOULD PASS, INDICATING A PARTIALLY BROKEN CONDUCTOR WIRE. NO OBVIOUS DAMAGE WAS SEEN ON THE CONDUCTOR WIRE AT THE DISTAL END THROUGH VISUAL AND MICROSCOPIC INSPECTION. THE INSTRUMENT WAS PARTIALLY DISASSEMBLED. WITH A SLIGHT TUG TO THE CONDUCTOR WIRE IT WAS CONFIRMED THAT THE WIRE HAD BROKEN AT THE PROXIMAL END, NEAR THE INTERNAL HYPOTUBE-CABLE JUNCTION. THE INTERNAL HYPOTUBE JUNCTION IS WITHIN THE MAIN TUBE, NEAR WHERE THE MAIN TUBE MEETS THE LOWER CHASSIS. THERMAL DAMAGE WAS OBSERVED TO THE FLUSH TUBE, HYPOTUBES, AND CONDUCTOR WIRE INSULATION, LIKELY DUE TO USE WHILE THE WIRE WAS PARTIALLY SEVERED. THE COMPLAINT REGARDING, INSTRUMENT WAS NOT FUNCTIONAL, WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOT FUNCTIONAL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: INTRAOPERATIVELY, THE INSTRUMENT STOPPED DELIVERING ENERGY; SWAPPING THE CABLE DID NOT HELP. THERE WERE NO VISIBLE DEFECTS ON THE INSTRUMENT AND NO BROKEN CABLES, BUT THE DEVICE DID NOT SUPPLY POWER. THE ISSUE WAS RESOLVED ONLY AFTER REPLACING IT WITH A NEW INSTRUMENT, AFTER WHICH ENERGY DELIVERY WORKED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183817 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K10250221 0136 00886874112298

    Patients

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