BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16882806 · Received May 6, 2023

    Report

    Report Number
    2955842-2023-12421
    Event Type
    Malfunction
    Date Received
    May 6, 2023
    Date of Event
    February 20, 2023
    Report Date
    April 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112366
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE ENGAGEMENT ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE NO FAILURE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED. THE TENACULUM FORCEPS WERE ANALYZED AND THE COMPLAINT REGARDING ENGAGEMENT WAS NOT CONFIRMED BY FAILURE ANALYSIS. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE WERE ALSO IDENTIFIED. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN DISTAL PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. WHEN PITCH CABLE BREAKAGE OCCURS, THE INSTRUMENT IS IMMEDIATELY INOPERABLE DUE TO LOSS OF FUNCTIONALITY. THE INSTRUMENT HAS TUNGSTEN DRIVE CABLES TO TRANSMIT MOTION FROM THE INPUT DISCS IN THE HOUSING, THROUGH THE MAIN SHAFT, AND TO THE DISTAL INSTRUMENT TIP. THESE CABLES ARE EXPOSED AT THE INSTRUMENT TIP AND CONTROL MOVEMENTS AT THE WRIST. THE TENACULUM FORCEPS INSTRUMENT IS CURRENTLY ASSOCIATED WITH CORRECTIVE ACTIONS REGARDING THE DESIGN TO CHANGE THE PITCH CABLE ALLOWING FOR CRIMP RETENTION. THIS DESIGN CHANGE WILL ENSURE THAT THE PITCH CABLE CRIMP IS RETAINED EVEN IF THE CABLE BREAKS TO MITIGATE THE POTENTIAL FOR A FRAGMENT FALLING INTO THE PATIENT AND TO IMPROVE PITCH CABLE LIFE. NO ADDITIONAL ACTIONS ARE REQUIRED GIVEN THAT A DESIGN CHANGE IS IN PROGRESS TO HELP REDUCE THE SEVERITY OF PITCH CABLE FAILURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: THIS INSTRUMENT IS DESIGNED WITH TWO PITCH CABLES EACH WITH A CRIMP AT THE DISTAL END. IF A PITCH CABLE BREAKS AT THE DISTAL END, A CABLE SEGMENT AND/OR THE CRIMP COULD FALL INTO THE PATIENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE INSTRUMENT TENACULUM FORCEPS HAD AN ENGAGEMENT ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692144 ENDOWRIST TENACULUM FORCEPS NAY INTUITIVE SURGICAL, INC 470207-08 N10171204 0059 00886874112366

    Patients

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