BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15859593 · Received November 23, 2022

    Report

    Report Number
    2955842-2022-15510
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    October 26, 2022
    Report Date
    October 26, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE RIGHT MASTER TOOL MANIPULATOR (MTMR) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE MTM INVOLVED WITH THIS COMPLAINT AND COMPLETED FAILURE ANALYSIS. THE MTM WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE OF WORN OPTO BUTTONS ALONG AXIS 8 AND GIMBAL GRIP WAS ABLE TO BE REPRODUCED DURING VISUAL INSPECTION. THE OPTO BUTTON ASSEMBLIES WILL BE REPLACED AS A FIX. THE COMPLAINT REGARDING PHYSICAL DAMAGE WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE SITE¿S SYSTEM LOGS IDENTIFIED AN INGUINAL HERNIA ¿ UNILATERAL AND AN INCISIONAL HERNIA ETEP, WERE PERFORMED ON 26-OCT-2022 ON SYSTEM SK0177. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. NO ADDITIONAL ACTIONS ARE CURRENTLY REQUIRED GIVEN THAT THIS ISSUE WILL CONTINUE TO BE TRACKED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE MTM WAS IN AN UNACCEPTABLE STATE AFTER THE START OF THE PROCEDURE. THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY, HOWEVER, THE MTM REQUIRED REPLACEMENT. 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. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT A PLASTIC KNUB ON RIGHT HAND CONTROL HAD FALLEN OFF. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF IT WAS RELATED TO THE SLIDER BUTTON AND THE CALLER STATED IT WAS. THE CUSTOMER WAS ABLE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758178 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-03 N/A

    Patients

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