BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22128965 · Received June 2, 2025

    Report

    Report Number
    2955842-2025-22258
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 7, 2025
    Report Date
    May 7, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER-REPORTED COMPLAINT. THE PRIMARY FAILURE OF A DISLODGED MAIN TUBE WAS FOUND TO BE DIRECTLY RELATED TO THE REPORTED ISSUE. THE MAIN TUBE WAS OBSERVED TO BE DISLODGED, WITH ITS METAL TABS DETACHED FROM THE SLOTS AT THE DISTAL END. AS A RESULT, THE INSTRUMENT FAILED THE IMPRECISE MOTION TEST. ADDITIONAL FINDINGS RELATED TO THE REPORTED COMPLAINT: THE INSTRUMENT EXHIBITED IMPRECISE MOTION WHEN THE MASTER TOOL MANIPULATORS (MTM) WERE ENGAGED. WHEN TESTED ON AN IN-HOUSE SYSTEM, THE INSTRUMENT PASSED BOTH RECOGNITION AND ENGAGEMENT TESTS. HOWEVER, DURING GRIPPING AND UNGRIPPING, IMPRECISE WRIST MOTION WAS NOTED. ALTHOUGH THE GRIP TIPS MOVED WITHIN JOINT LIMITS AND FOLLOWED THE COMMANDED DIRECTION, THERE WAS A NOTICEABLE LAG OR DELAY IN MOTION RESPONSE. 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 A DISLODGED MAIN TUBE IS ATTRIBUTED TO DAMAGE DURING USE. WHEN THE ROLL GEAR TABS THAT MATE WITH THE MAIN TUBE AND PROVIDE A HARD STOP ARE DAMAGED, THE MAIN TUBE CAN ROTATE INDEPENDENTLY OF THE ROLL GEAR. THIS ROTATION CAN CAUSE A MISCALIBRATION BETWEEN THE MTM AND MAIN TUBE. THE PROBABLE ROOT CAUSE OF IMPRECISE MOTION IS ATTRIBUTED TO THE DISLODGED MAIN TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER REPORTED THAT THE VESSEL SEALER EXTEND CAMERA DID NOT MOVE IN THE OPERATING DIRECTION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THE SURGEON WAS ABLE TO MOVE IT, BUT IT WAS AN UNINTENDED MOVEMENT. THE INSTRUMENT MOVED IN THE OPPOSITE DIRECTION TO THE HAND CONTROLLER. THE TIMING OF INSTRUMENT MOVEMENT WAS APPROPRIATE. UNKNOWN IF THERE WAS ANY SHAKINESS AND/OR FRICTION EXPERIENCED/OBSERVED. UNKNOWN IF THERE WAS ANY INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. UNKNOWN IF THERE WERE ANY EXTERNAL COLLISIONS. THE ISSUE OCCURRED MIDWAY THROUGH THE PROCEDURE. WHEN THE ISSUE OCCURRED, THE SURGEON CHANGED IT TO THE OTHER VSE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES IDENTIFIED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362457 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K18240517 0342 10886874115661

    Patients

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