BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24217134 · Received January 29, 2026

    Report

    Report Number
    2955842-2026-02621
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    December 5, 2025
    Report Date
    January 29, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE BENT GRIP, CAUSING MISALIGNMENT OF THE GRIPS-TIPS. THERE WAS A 0.16 MM OFFSET AT THE TIPS. A CLIP CAN BE PROPERLY LOADED INTO THE CLIP GROOVE OF THE GRIPS-TIPS. HOWEVER, THE CLIP COULD NOT BE APPLIED TO THE IN-HOUSE TEST TUBE DUE TO THE MISALIGNMENT CAUSED BY THE BENT GRIPS-TIPS. THE GRIPS WERE NOT FOUND TO HAVE CRACKING DAMAGE. ADDITIONAL OBSERVATION(S) : THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND DRIVEN. THE CLIP APPLIER INSTRUMENT FAILED THE CLIP TEST DUE TO MISAPPLICATION OF THE CLIP (E.G., THE INSTRUMENT PASSES ENGAGEMENT AND ABLE TO RETAIN CLIP THROUGH ENGAGEMENT BUT CANNOT APPLY THE CLIP). THE CLIP WAS INSTALLED ON TO THE CLIP APPLIER, UPON ACTIVATING THE CLIP APPLICATION THE CLIP WOULD NOT LOCK/CLIP TO THE TEST TUBING. THE CLIP STAYED ATTACHED TO THE CLIP APPLIER AND HAD TO BE MANUALLY REMOVED. COMMON CAUSES OF THE FAILURE MODE BENT INSTRUMENT GRIPS-TIPS ARE ATTRIBUTED TO DAMAGE DURING USE, AS MODERATE MISALIGNMENT OF GRIP TIPS CAN OCCUR DUE TO GRASPING HARD TISSUE OR OBJECTS, OR THROUGH COLLISIONS WITH OTHER INSTRUMENTS. COMMON CAUSES OF THE FAILURE MODE BENT INSTRUMENT GRIPS-TIPS ARE ATTRIBUTED TO DAMAGE DURING USE, AS MODERATE MISALIGNMENT OF GRIP TIPS CAN OCCUR DUE TO GRASPING HARD TISSUE OR OBJECTS, OR THROUGH COLLISIONS WITH OTHER INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS DISCOVERED BEFORE THE CLIP APPLIER WAS USED AND THERE WAS NO DETACHED PORTION OF THE DEVICE. NO IMPLICATION OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277670 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 N10190826 0106 00886874112465

    Patients

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