BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 23877842 · Received December 23, 2025

    Report

    Report Number
    2955842-2025-49536
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 23, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A SYSTEM LOG REVIEW WAS PERFORMED BY INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE) AND REPORTED THAT THE DIGITAL SIGNAL PROCESSOR (DSP) LOGS SHOW THAT THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS INSTALLED 7 TIMES AND PASSED HOMING 3 TIMES, FAILED 4 TIMES. THERE WERE 101 CUT COMPLETE AND 1 CUT FAILED EVENTS WERE NOTED. THERE WAS 1 BLADE DWELL RECOVERY AND BLADE JAMMED EVENTS NOTED. THE E100 LOGS SHOW 2 COAG EVENTS WITH NO ERRORS AND 190 SEAL EVENTS WITH 1 HIGH INITIAL STARTING IMPEDANCE ERROR. THE MASTER SUPERVISORY CONTROLLER (MSC) LOGS SHOW 1 HIGH INITIAL STARTING IMPEDANCE ERROR, 1 BLADE JAMMED ERROR AND 4 HOMING FAILED ERRORS AT THE SAME TIME STAMPS AS THOSE ABOVE. THE INSTRUMENT WAS USED FOR ABOUT 44 MINUTES. IT IS LIKELY THAT THE USER TRIED TO CUT EXCESSIVE TISSUE WHICH IS WHY THE BLADE JAMMED AND CUT FAILED ERRORS WERE SEEN. IT IS POSSIBLE THAT THERE WAS AN EXPOSED BLADE BECAUSE OF A FAILED CUT TEST COULD HAVE LED TO THE HOMING FAILURES OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ROBOTIC AMPUTATION OF THE RECTUM, A TISSUE WAS CAUGHT IN THE VESSEL SEALER EXTEND (VSE) INSTRUMENTS GRIPS. THE JAWS REMAINED OPEN AND IT STOPPED WORKING. THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARM HAD A FLASHING ORANGE ALARM. THE VSE WAS USED IN DISSECTION OF TISSUES IN THE SMALL PELVIS, MOSTLY VASCULARIZED ADIPOSE TISSUE. THE SURGEON PERFORMED TOTAL MESORECTAL EXCISION WITH INTERRUPTION OF THE LATERAL RAILS, AND INTERRUPTED THE MIDDLE AND LOWER COLIC. DURING DISSECTION OF THE TISSUES IN THE DISTAL PART OF THE SMALL PELVIS, THE VSE SUDDENLY STOPPED WORKING. THE VSE HAD TO BE PULLED WITH THE TISSUE, AND A PIECE OF "UNBROKEN" TISSUE REMAINED IN THE INSTRUMENT. THE SURGEON TRIED TO CLEAN THE VSE JAWS; HOWEVER, THE JAWS REMAINED OPEN AND INOPERABLE. SINCE, THE SURGERY IS NEARING COMPLETION, THE SURGEON DECIDED NOT TO USE THE BACKUP VSE INSTRUMENT, INSTEAD, THE SURGEON USED SCISSORS AND ELECTROCOAGULATION TO COMPLETE THE PROCEDURE WHICH CAUSED UNSPECIFIED AMOUNT OF TIME OF PROCEDURAL DELAY. THERE WAS NO PATIENT HARM, INJURY OR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517146 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K11250627 0179 10886874115661

    Patients

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