BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 11450690 · Received March 10, 2021

    Report

    Report Number
    2955842-2021-10234
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    December 10, 2020
    Report Date
    February 12, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111659
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT "INSTRUMENT DOES NOT HAVE FULL RANGE OF MOTION". FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF FAILED INTUITIVE MOTION TEST TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THIS INSTRUMENT¿S GRIP TIPS WERE NOT MOVING INTUITIVELY, I.E. THEY WERE NOT FOLLOWING THE MASTER TOOL MANIPULATOR (MTM) INPUT COMMANDS SMOOTHLY. ADDITIONAL OBSERVATION NOT REPORTED BY SITE THAT IS RELATED TO THE PRIMARY FAILURE: THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. A SITE HISTORY WAS PERFORMED AND NO RELATED COMPLAINTS WERE FOUND. A REVIEW OF SYSTEM LOGS SHOWED THAT THE TENACULUM FORCEPS WAS LAST USED ON SYSTEM NUMBER (B)(4) ON (B)(6) 2020 AND IT HAD 9 LIVES REMAINING. NO IMAGE OR VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE TENACULUM FORCEPS 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. ALTHOUGH NO PATIENT HARM WAS REPORTED, IF THE ISSUE WERE TO RECUR, IT COULD POTENTIALLY RESULT IN AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, THE TENACULUM FORCEPS DID NOT HAVE FULL RANGE OF MOTION. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER STATED THAT HE COULD NOT ANSWER THE FOLLOW UP QUESTIONS AS THEY PERTAINED TO PATIENT CONFIDENTIALITY. NO FURTHER DETAILS ABOUT THE REPORTED EVENT WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351407 ENDOWRIST;DAVINCI SI TENACULUM FORCEPS NAY INTUITIVE SURGICAL, INC 420207-09 N10190327 126 00886874111659

    Patients

    Seq Age Sex Outcome Treatment
    1