BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23176898 · Received September 30, 2025

    Report

    Report Number
    2955842-2025-39903
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 9, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE LARGE HE-O-LOK CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS ANALYZED AND IT WAS FOUND TO HAVE A LOOSE GRIP CABLE AT THE PROXIMAL END. ADDITIONAL OBSERVATION: THE CLIP APPLIER INSTRUMENT FAILED THE CLIP TEST. THE CLIP COULD BE INSTALLED ONTO GRIPS BUT, IT DID NOT FULLY CLOSE. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS WHEN PLACED ON AN IN-HOUSE SYSTEM. THE PROBABLE ROOT CAUSE OF DIFFICULTY APPLYING A CLIP IS ATTRIBUTED TO THE DAMAGED GRIP CABLE LEADING TO A LOSS OF FUNCTIONALITY. THE CLIP APPLIER INSTRUMENT FAILED THE CLIP TEST DUE TO MISAPPLICATION OF THE CLIP.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    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 CLIP COULD NOT BE HELD. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO VISIBLE DAMAGE. THE INCIDENT WITH THE CLIP APPLIER OCCURRED WHEN THE SURGEON TRIGGERED THE CLIP AND IT DID NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409580 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 K10221204 0159

    Patients

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