BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 24799624 · Received April 7, 2026

    Report

    Report Number
    2955842-2026-20361
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 7, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR. THE BROKEN PIECE MEASURES APPROXIMATELY 16.38MM X 4MM, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT AND WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DID NOT APPEAR TO BE BENT. ADDITIONAL OBSERVATION(S) RELATED TO CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A DETACHED INTACT JAW FROM THE GRIP BASE. BASED ON VISUAL INSPECTION AND ANALYSIS OF THE RETURNED DEVICE. THE MOLDED INSULATOR BREAKS FIRST AND SEPARATING FROM THE JAW. THE JAW SUBSEQUENTLY SEPARATED FROM THE GRIP BASE DUE TO LOSS OF MECHANICAL SUPPORT FROM THE MOLDED INSULATOR, THE BIPOLAR CONDUCTOR WIRE BROKE AS A RESULT OF INCREASED MECHANICAL STRESS DURING JAW DETACHMENT. AS OF RESULT, THE INTACT JAW AND BROKEN MOLDED INSULATOR FULLY DETACHED FROM THE INSTRUMENT ASSEMBLY. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BIPOLAR CONDUCTOR WIRE AT THE DISTAL END. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED. THE IMAGES SHOW A FORCE BIPOLAR INSTRUMENT WITH A BROKEN MOLDED INSULATOR, WHICH RESULTED IN A DETACHED JAW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS GRABBING TISSUE AND SUDDENLY, A BIG CHUNK OF ONE SIDE OF THE JAWS CRACKED OFF; THE PIECE CAME OFF IN 2 PIECES, WHICH WERE BOTH RETRIEVED FROM THE BODY. THE FORCE BIPOLAR INSTRUMENT WAS REMOVED FROM THE BODY, AND A NEW ONE WAS OPENED TO COMPLETE THE PROCEDURE. THE CUSTOMER SENT EVERYTHING TO BE CLEANED FOR RETURN AND THE INSTRUMENT, AND THE LARGE PIECE OF THE JAWS CAME BACK MISSING A LITTLE PIECE OF THE PLASTIC, WHICH WAS TINY AND GOT LOST ALONG THE WAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SCRUB TECH CONFIRMED THAT THE INSTRUMENTS WERE INSPECTED BEFORE USE AND NO DAMAGE WAS NOTED. DURING THE PROCEDURE, THE SURGEON WAS GRASPING TISSUE WHEN THE INSTRUMENT BROKE UNEXPECTEDLY, DESPITE NOT APPLYING SIGNIFICANT FORCE. THE INSTRUMENT HAD NOT BEEN IN USE FOR VERY LONG, AND THERE WERE NO PRIOR FUNCTIONAL ISSUES OR COLLISIONS WITH OTHER INSTRUMENTS. THE FRAGMENTS FELL INTO THE PATIENT WITHOUT A COLLISION; ALL IDENTIFIABLE PIECES WERE RETRIEVED USING A LAPAROSCOPIC GRASPER, WITH NO ADDITIONAL PROCEDURES REQUIRED. NO POSTOPERATIVE IMAGING WAS PERFORMED, AND THE SURGERY WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT OR SUBSEQUENT COMPLICATIONS. THE INSTRUMENT AND THE LARGER FRAGMENT WERE RETURNED TO INTUITIVE FOR EVALUATION; THE SMALLER FRAGMENT WAS LOST DURING CLEANING. A PHOTO OF THE DEVICE AND FRAGMENT WAS TAKEN BEFORE SHIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442324 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K13260115 0215 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1