BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17015896 · Received May 28, 2023

    Report

    Report Number
    2955842-2023-15015
    Event Type
    Malfunction
    Date Received
    May 28, 2023
    Date of Event
    October 26, 2021
    Report Date
    November 17, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112427
    PMA / PMN Number
    K140553
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE STAPLER 45 INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS RETURNED WITH A WHITE RELOAD IN THE JAW. THE RELOAD WAS REMOVED AND THE INSTRUMENT WAS TESTED IN HOUSE. DURING IN HOUSE TESTING INSTRUMENT FAILED DURING INITIALIZATION. THE INSTRUMENT WAS FOUND TO HAVE AN UNCLAMP FAILURE BASED ON LOG REVIEW. ADDITIONAL ANALYSIS WAS PERFORMED ON THE INSTRUMENT BY AN ADVANCED FAILURE ANALYSIS ENGINEER. INSTRUMENT FAILED TO UNCLAMP PER LOGS, BUT UNCLAMP FAILURE WAS NOT REPLICATED DURING IN-HOUSE TESTING. INITIALIZATION FAILURE THAT OCCURRED DURING INITIAL FAILURE ANALYSIS WAS LIKELY A RESULT OF USING THE STAPLER RELEASE KIT (SRK) TO MANUALLY UNCLAMP THE INSTRUMENT IN-HOUSE. THE SRK USE LIKELY JAMMED THE CLAMP MECHANISM, CAUSING A JAMMED MECHANISM HOMING FAILURE. INSTRUMENT WAS UNJAMMED IN-HOUSE AND THE INSTRUMENT PASSED INITIALIZATION AND WAS ABLE TO CLAMP, FIRE, AND UNCLAMP SUCCESSFULLY WITH A PLASTIC TEST SHEET INSTALLED. HOWEVER, WHEN CLAMP PERFORMANCE WAS TESTED VIA A SHIM TEST, THE INSTRUMENT FAILED TO CLAMP ON THE 0.032" SHIM IN THE PITCH DOWN POSITION ON MULTIPLE ATTEMPTS. CLAMPING FAILED IN THE PITCH DOWN WRIST ORIENTATION. VISUAL INSPECTION OF WRIST COMPONENTS SHOWED THAT THE YAW PLATE WAS BENT OUTWARDS TOWARDS THE CLAMP CARDAN AND THE PIVOT PIN WAS BROKEN. ADDITIONALLY, WITNESS MARKS WERE OBSERVED ON THE CLAMP CARDAN SHELL THAT MAY BE INDICATIVE OF THE CARDAN RUBBING AGAINST OTHER COMPONENTS DURING CLAMPING/UNCLAMPING. EVIDENCE SUGGESTS THAT THE COMPONENT DAMAGE AT THE WRIST MAY BE RELATED TO THE UNCLAMP FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, THE STAPLER 45 DID NOT FIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT INJURY. THE ISSUE WAS RESOLVED BY USING ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849841 ENDOWRIST STAPLER 45 NAY INTUITIVE SURGICAL, INC 470298-14 T10200716 0097 00886874112427

    Patients

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