BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25210594 · Received May 18, 2026

    Report

    Report Number
    2955842-2026-25484
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 18, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874114817
    PMA / PMN Number
    K162973
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUCTION IRRIGATOR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MAIN TUBE APPROXIMATELY .085" FROM THE DISTAL TIP. NO MATERIAL WAS FOUND MISSING. COMPONENTS ADJACENT TO THIS BROKEN MAIN TUBE DO SHOW DAMAGE. THE SNAKE WRIST IS DISLODGED, THE INNER LUMEN IS BROKEN, AND SNAKE WRIST CABLE IS BROKEN. ADDITIONAL OBSERVATIONS RELATED TO CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED SNAKE WRIST AT THE WRIST DISK END CAP, WHICH CAUSED THE WRIST DISKS TO MISALIGN. THERE WERE NO MISSING PIECES, AND DAMAGE WAS OBSERVED TO THE SNAKE WRIST CABLES. WRIST ASSEMBLY IS NOT STRAIGHT AND DID ADVANCE THROUGH A CANNULA. OTHER COMPONENTS ADJACENT TO THE DISLODGED SNAKE WRIST DO SHOW DAMAGE WHICH MAY INDICATE POTENTIAL MISHANDLING AND MISUSE. THE MAIN TUBE IS BROKEN, THE INNER LUMEN IS BROKEN, AND SNAKE WRIST CABLE IS BROKEN. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN SNAKE WRIST CABLE AT THE DISTAL END. THE CABLE WAS FULLY BROKEN. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. THE COMPONENTS SURROUNDING THE BROKEN CABLE DID EXHIBIT DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE CABLE BREAKING. THE MAIN TUBE IS BROKEN, THE INNER LUMEN IS BROKEN, AND SNAKE WRIST IS DISLODGED. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN INNER LUMEN AT THE DISTAL END. COMMON CAUSES OF THE FAILURE MODE BROKEN INSTRUMENT MAIN TUBE ARE ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM AN ACCIDENTAL DROP OF THE INSTRUMENT OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS. EXCESSIVE SIDE LOADING ON THE INSTRUMENT CAN ALSO CAUSE THE MAIN TUBE WALL TO COLLAPSE INWARDS CAUSING IT TO CRACK AND SUBSEQUENTLY BREAK. COMMON CAUSES OF THE FAILURE MODE DISLODGED INSTRUMENT SNAKE WRIST ARE ATTRIBUTED TO USE CONDITIONS. COMMON CAUSES OF BROKEN - DISTAL INSTRUMENT SNAKE WRIST CABLE WHETHER PARTIAL OR FULL, ARE COMMONLY ATTRIBUTED TO DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING TRANSPORT/STORAGE, DURING USE, OR DURING REPROCESSING. THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395359 ENDOWRIST SUCTION IRRIGATOR NAY INTUITIVE SURGICAL, INC 480299-08 K13250919 0049 10886874114817

    Patients

    Seq Age Sex Outcome Treatment
    1