BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23796097 · Received December 12, 2025

    Report

    Report Number
    2955842-2025-48577
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 21, 2025
    Report Date
    January 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112380
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE CLIP APPLIER WAS EVALUATED FOR JAW ARTICULATION AND ROTATION. THE JAWS ARTICULATED AS DESIGNED AND ROTATED SMOOTHLY THROUGH THE FULL RANGE OF MOTION. THE INSTRUMENT PASSED THE CLIP TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE HAIRLINE CRACKS ON GRIP INPUT SHAFT #6 AND #7. OTHER BACKEND COMPONENTS ADJACENT TO THE CRACKED INPUTS DO NOT SHOW DAMAGE. THE COMPLAINT REGARDING THE JAW WAS NOT ARTICULATING, WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. THE PROBABLE ROOT CAUSE OF CRACKS ON GRIP INPUT SHAFTS IS ATTRIBUTED TO DAMAGE DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT JAW WAS NON-ARTICULATING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER STATED THAT THE ISSUE OCCURRED WHILE ATTEMPTING TO CLIP A VESSEL OR TISSUE BUNDLE. THEY DID EXPERIENCE LIMITED MOTION ISSUES WHEN USING THE CLIP APPLIER. IT IS UNKNOWN WHAT CLIP APPLICATION THE ISSUE OCCURRED ON. THEY USED ANOTHER INSTRUMENT TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249909 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 K10230405 0067 00886874112380

    Patients

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