BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 23109672 · Received September 22, 2025

    Report

    Report Number
    2955842-2025-38437
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 8, 2025
    Report Date
    January 6, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D9, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED BOTH THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE TIPS OPENED AND CLOSED AS EXPECTED. THERE WERE NO REPORTED RECOGNITION OR ENGAGEMENT FAILURES IN THE LOG. THE INSTRUMENT WAS FULLY FUNCTIONAL, WITH NO PRODUCT ISSUE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER SHOWS THE HOUSING, PRODUCT BOX, AND DISTAL TIP OF A MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT. NO PRODUCT FAILURES OR ISSUES WERE IDENTIFIED. THE VIDEO SHOWS AN MBF GRASPING A NEEDLE DRIVER INSTRUMENT. IT SHOULD BE NOTED THAT THE MBF INSTRUMENT IS NOT INDICATED FOR NEEDLE DRIVING OR SUTURING. THE USER IS ROTATING THE MBF INSTRUMENT AROUND ITS ROLL AXIS AND IS REACHING THE RANGE OF MOTION (ROM) LIMIT FOR THIS AXIS. THIS IS INDICATED BY THE "RELAX HAND CONTROL" MESSAGE ON THE USER INTERFACE (UI) ARM POD. AS THE USER CONTINUES TO TRY AND OVERCOME THE ROM BOUNDARY, THE MBF INSTRUMENT CHANGES POSITIONS IN AN ATTEMPT TO FOLLOW THE USER'S CONTROLS. THE VIDEO CLIP ENDS AFTER THE MBF INSTRUMENT CHANGES POSITION ONCE MORE. IT APPEARS THAT THE USER EXPERIENCED MOTION ISSUES DUE TO REPEATEDLY ENCOUNTERING THE ROM LIMITS, WHICH PREVENTED THEM FROM EXCEEDING THESE LIMITS AS INTENDED BY THE SYSTEM'S DESIGN. IT COULD NOT BE DETERMINED WHETHER THE INSTRUMENT'S MOTION DID OR DID NOT MATCH THE USER'S HAND CONTROLS SINCE THE VIDEO ONLY PROVIDED AN ENDOSCOPIC VIEW. NO INJURY OCCURRED DURING THE VIDEO CLIP. THE USER MAY HAVE BEEN ATTEMPTING TO RECREATE A SPECIFIC BEHAVIOR WHILE CAPTURING THE VIDEO.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE TIP OF THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT BECAME UNCONTROLLABLE, RESULTING IN AN ARTERIAL PUNCTURE THAT CAUSED BLEEDING. CONSEQUENTLY, THE PROCEDURE APPROACH WAS CONVERTED TO LAPAROSCOPIC. THE FOLLOWING INFORMATION IS UNKNOWN: WHAT VESSEL WAS SPECIFICALLY INJURED, THE ESTIMATED BLOOD LOSS, AND WHAT MEDICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027568 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-17 K10241017 0371

    Patients

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