BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22790973 · Received August 13, 2025

    Report

    Report Number
    2955842-2025-33969
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 23, 2025
    Report Date
    July 23, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2022-05-C, ISIFA202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WAS FOUND TO HAVE A BENT GRIP AND THE TIP DOES NOT ALIGN WITH THE OTHER GRIP. THE GRIPS DO NOT SHOW CRACKING DAMAGE. COMPONENTS ADJACENT TO THIS BENT GRIP SHOW DAMAGE WHICH MAY INDICATE POTENTIAL MISHANDLING/MISUSE / DO NOT SHOW DAMAGE. COMMON CAUSES OF THE FAILURE MODE BENT INSTRUMENT GRIPS TIPS ARE ATTRIBUTED TO DAMAGE DURING USE, AS MODERATE MISALIGNMENT OF GRIP TIPS CAN BE DUE TO GRASPING EITHER HARD TISSUE/OBJECTS OR COLLISIONS WITH OTHER INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLIP APPLIER WOULD NOT CLIP PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED BY SPD PERSONNEL. ISSUE OCCURRED DURING SURGICAL CASE WHILE LOADING THE CLIP ONTO THE CLIP APPLIER. NOT SURE IF THE ISSUE WAS RELATED TO CLIP APPLIER JAWS REMAINING STATIC/NOT MOVING WHEN SURGEON COMMANDED MOVEMENT OR TO UNEXPECTED MOTION OF CLIP APPLIER WHILE ATTEMPTING TO CLIP (E.G., THE INSTRUMENT¿S JAW SWAYED TO THE SIDE). NOT SURE IF THERE WAS AN UNSUCCESSFUL CLIP APPLICATION. NOT SURE IF THERE WAS AN OPENING OF THE CLIP AFTER PLACEMENT. NOT SURE WHAT TYPE OF CLIPS WERE USED FOR THE PROCEDURE. NOT SURE WHAT THE SIZE OF THE VESSEL WAS. NOT SURE HOW THE ISSUE WAS RESOLVED. THE INSTRUMENT WAS RETURNED TO ISI FOR ANALYSIS. NO PHOTOS OR VIDEOS ARE AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624310 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K10240822 0452 00886874112465

    Patients

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