BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 23359160 · Received October 22, 2025

    Report

    Report Number
    2955842-2025-42461
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 23, 2025
    Report Date
    September 23, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A LOOSE GRIP CABLE AT THE PROXIMAL END. AS A RESULT OF THE LOOSE GRIP CABLE, THE INSTRUMENT JAWS WOULD NOT CLOSE FULLY, CAUSING THE INSTRUMENT TO FAIL TO DELIVER ENERGY. THERE WAS NO DAMAGE FOUND TO THE CONDUCTOR WIRE, AND THE GRIP CABLE WAS NOT BROKEN. ADDITIONAL OBSERVATION(S) RELATED TO CUSTOMER-REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE LOW TORQUE FAILURES BASED ON LOG REVIEW. VISUAL INSPECTION REVEALED A LOOSE GRIP CABLE IN THE BACKEND. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT PASSED THE HOMING TEST. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE CUT TEST BUT FAILED TO SEAL ON 1 OF 2 ATTEMPTS. THERE WERE ERROR CODES INDICATING THAT THE INSTRUMENT EXHIBITED LOW TORQUE DURING USE, WHICH TYPICALLY RESULTS IN A SEALING MALFUNCTION. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. LOW TORQUE ERRORS ARE OFTEN CAUSED DUE TO A LOOSE GRIP CABLE IN THE PROXIMAL END, WHICH COULD BE DUE TO COMPONENT FAILURE ON ACCOUNT OF USAGE OR DUE TO A MANUFACTURING ERROR, WHERE THE GRIP CLAMPING PULLEY HAS A LOOSE SCREW. THE INSTRUMENT WAS FOUND TO HAVE FAILED MECHANICAL ENGAGEMENT BASED ON LOG REVIEW. THE LOGS CONFIRMED THAT THREE ENGAGEMENT FAILURES OCCURRED ON CORRELATING INSTALLS OF THIS INSTRUMENT IN THE FIELD. THE PARAMETERS OF THE ENGAGEMENT FAILURES INDICATE THAT THE WRIST PITCH AXIS FAILED TO ENGAGE. THE LOGS SHOW THAT THE VESSEL SEALER EXTEND (VSE) INSTRUMENT LOT# K17250416-0279 WAS INSTALLED EIGHT TIMES AND PASSED HOMING EIGHT TIMES. THERE WERE 98 CUT COMPLETE EVENTS AND 93 SEAL EVENTS NOTED. A TOTAL OF 3 JAW ANGLE OPEN EVENTS WERE OBSERVED, WHICH ARE LIKELY RELATED TO THE CUSTOMER¿S COMPLAINT OF JAWS NOT CLOSING ALL THE WAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE, THE VESSEL SEALER EXTEND (VSE) JAWS WERE NOT CLOSING ALL THE WAY WHICH CAUSED A LITTLE MORE BLEEDING THAN USUAL. THE INSTRUMENT WAS INSPECTED PRIOR TO USE, WITH NO UNUSUAL FINDINGS NOTED. THE VSE INSTRUMENT FUNCTIONED AS EXPECTED FOR PART OF THE PROCEDURE UNTIL, DURING A VESSEL SEALING PROCESS, IT WAS OBSERVED THAT THE JAWS WERE NOT CLOSING COMPLETELY. NO ERRORS OR ALARMS WERE RECORDED. THE TARGET VESSEL WAS LESS THAN 7 MILLIMETERS IN DIAMETER AND SHOWED NO CALCIFICATION. A BACKUP INSTRUMENT WAS USED TO SUCCESSFULLY SEAL THE BLEEDING AREA. THE ESTIMATED BLOOD LOSS WAS LESS THAN 20 CC. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO ADVERSE PATIENT IMPACT OR COMPLICATIONS, AND THE PATIENT DID NOT REQUIRE AN EXTENDED HOSPITAL STAY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222159 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 0307 10886874115661

    Patients

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