BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24584663 · Received March 12, 2026

    Report

    Report Number
    2955842-2026-15835
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    November 20, 2025
    Report Date
    March 12, 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
    SP
    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 TWO (2) SEVERELY BENT GRIPS, CAUSING MISALIGNMENT OF THE GRIP-TIPS. THERE WAS A 0.42 MM OFFSET AT THE TIPS. A CLIP CAN BE PROPERLY LOADED INTO THE CLIP GROOVE OF THE GRIP-TIPS, BUT CAN NOT BE PROPERLY RELEASED DURING THE CLIP TEST. THE GRIPS WERE NOT FOUND TO HAVE CRACKING DAMAGE. ADDITIONAL RELATED OBSERVATION: 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 PROPERLY ATTACHED TO THE TUBING, BUT AFTER THAT COULD NOT BE RELEASED FROM THE SEVERELY BEND GRIP TIP. COMMON CAUSES OF THE FAILURE MODE BENT-SEVERELY INSTRUMENT GRIPS -TIPS ARE ATTRIBUTED TO DAMAGE DURING EITHER USE OR REPROCESSING, AS SEVERE MISALIGNMENT OF GRIP TIPS CAN BE DUE TO ACCIDENTAL DROPS, INCORRECT INSTRUMENT TRAY OR SINK SIZES FOR REPROCESSING, OR OVERLOADING THE TIPS BY APPLYING EXCESSIVE FORCE ON THE JAWS. COMMON CAUSES OF LOSS OF FUNCTIONALITY TO APPLY A CLIP ARE ATTRIBUTED TO EITHER A DAMAGED GRIP CABLE OR MISALIGNED GRIPS OR BENT GRIP TIPS. THE ROOT CAUSE OF THIS FAILURE MODE IS ATTRIBUTED TO THE PRIMARY FAILURE OF SEVERELY BENT INSTRUMENT GRIP TIPS.

    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. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED WHILE LOADING THE CLIP ONTO THE CLIP APPLIER (OUTSIDE OF PATIENT). THERE WEREN'T ANY MOTION ISSUES. BY THE TIME THE INCIDENT OCCURRED, THE CLIP APPLIER HAD BEEN USED 2 TIMES. THE CUSTOMER USED A BACK-UP TO PROCEED WITH THE PROCEDURE. THERE AREN'T ANY IMAGES OR VIDEOS FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383768 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-15 K10241114 0404 00886874112465

    Patients

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