BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23238953 · Received October 7, 2025

    Report

    Report Number
    2955842-2025-40736
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 10, 2025
    Report Date
    September 10, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE VSE INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS NOT ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT. VISUAL INSPECTION REVEALED DAMAGE TO THE MAIN TUBE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT FAILED THE RECOGNITION AND ENGAGEMENT TESTS. DUE TO THE BENT MAIN TUBE, THE INSTRUMENT WOULD NOT ENGAGE WITH THE STERILE ADAPTERS. THE GRIPS OPENED AND CLOSED PROPERLY. NO FAILURES WERE FOUND IN THE LOGS. NO PRODUCT ISSUE WAS IDENTIFIED RELATED TO THE JAWS BEING STUCK TO TISSUE. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES. THE PROBABLE ROOT CAUSE OF A BENT MAIN TUBE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM AN ACCIDENTAL DROP OF THE INSTRUMENT OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS. APPLYING EXCESSIVE FORCE ON THE INSTRUMENT SHAFTS AND/OR TIPS DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL CAN ALSO CAUSE BENDING. ONCE THE INSTRUMENT IS RECOGNIZED ON THE DA VINCI SYSTEM, ENGAGEMENT GETS CHECKED. THE ENGAGEMENT SEQUENCE RUNS FOR EACH INSTALLATION OF THE INSTRUMENT TO ENSURE PROPER MATING AND TRANSMISSION OF FORCE BETWEEN USM CARRIAGE OUTPUTS, INSTRUMENT STERILE ADAPTER, AND INSTRUMENT INPUT DISKS. SUCCESSFUL ENGAGEMENT IS DETECTED BY DRIVING THE INSTRUMENT STERILE ADAPTER THROUGH A PREDEFINED TRAJECTORY. THE PROBABLE ROOT CAUSE OF ENGAGEMENT FAILURES IS ATTRIBUTED TO AN OVER-CONSTRAINED DESIGN CONDITION BETWEEN THE MATING PARTS OF THE INSTRUMENT AND INSTRUMENT STERILE ADAPTER DISKS. THIS INSTRUMENT UNDERWENT ENGAGEMENT IMPROVEMENTS THROUGH A SOFTWARE UPDATE. THE INSTRUMENT STERILE ADAPTER ON THE ARM DRAPE ALSO UNDERWENT A DESIGN CHANGE THAT ADDED A TILTING FEATURE TO IMPROVE ENGAGEMENT BETWEEN THE UNIVERSAL SURGICAL MANIPULATOR (USM), DRAPE, AND INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT DID NOT SEEM TO BE WORKING AT FULL STRENGTH AND THE JAWS WERE STUCK TO TISSUES AFTER THE END OF CYCLE TONE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY AND LESS THAN A 15-MINUTE DELAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: OVERALL SURGEON BECAME FRUSTRATED DURING DISSECTION THAT THE VSE INSTRUMENT JAWS WERE GETTING STUCK TO TISSUES AT THE END OF CYCLE TONE AND REQUESTED ANOTHER TO BE OPENED. THE INSTRUMENT HAD BEEN IN USE FOR ABOUT AN HOUR, THERE WAS SOME BIOBURDEN ON THE INSTRUMENT JAWS, THE JAWS WHERE THE TISSUE WAS GETTING STUCK. THERE WAS NO SIGNIFICANT BLOOD LOSS DUE TO THIS ISSUE OR HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747021 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K13250522 0369

    Patients

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