BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23674443 · Received November 28, 2025

    Report

    Report Number
    2955842-2025-46736
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 18, 2025
    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
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE. WHEN CABLE BREAKAGE OCCURS, THE INSTRUMENT IS IMMEDIATELY INOPERABLE DUE TO LOSS OF FUNCTIONALITY. THE INSTRUMENT HAS TUNGSTEN DRIVE CABLES TO TRANSMIT MOTION FROM THE INPUT DISCS IN THE HOUSING, THROUGH THE MAIN SHAFT, AND TO THE DISTAL INSTRUMENT TIP. THESE CABLES ARE EXPOSED AT THE INSTRUMENT TIP AND CONTROL MOVEMENTS AT THE WRIST. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF CABLE BREAKAGE, WHETHER PARTIAL OR FULL, IS ATTRIBUTED TO DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS DIDN¿T CLOSE THE JAWS AND NOTICE THAT THE WIRE OF THE PULLEY WAS CUT, SO THEY REPLACED THE INSTRUMENT WITH A BACKUP INSTRUMENT AND CONTINUED THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED 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
    2136520 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-21 K13250320 0346 00886874112298

    Patients

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