BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14539125 · Received May 29, 2022

    Report

    Report Number
    2955842-2022-11898
    Event Type
    Malfunction
    Date Received
    May 29, 2022
    Date of Event
    April 29, 2022
    Report Date
    April 29, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) HAS CONTACTED THE CUSTOMER AND THE CUSTOMER CONFIRMED THE REPORTED ISSUE WAS USER INDUCED AND THAT THERE WERE NO FURTHER ISSUES. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED. VERIFICATION OF THE EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME BECAUSE THERE IS INSUFFICIENT EVENT DATE INFORMATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: /19424/22020/INSTALLED 0° SCOPE (8.5MM WAHOO_COT) FAILED TO ENGAGE ON USM2 (ROLL AXIS FAILED TO ENGAGE)./8/PCTP_ID/113/1/5100135/488913372/1048560/810550/A70_P9_L1_B710/66416995/9631719/LOG_TOOL_ENGAGEMENT_FAILED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A USM WAS DISABLED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING 3 ARMS. 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 PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY-BENIGN SURGICAL PROCEDURE, THE CUSTOMER CALLED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT ARM 2 WON'T RECOGNIZE THE ENDOSCOPE. THE STAFF MOVED THE ENDOSCOPE TO ARM 3 AND REMOVED ARM 2 FROM THE PATIENT PRIOR TO CALLING IN. TSE REVIEWED THE ONSITE LOGS TO CONFIRM ERROR 22020 ON ARM 2. THE TSE SUGGESTED THAT THE SURGICAL STAFF COULD HAVE A STERILE ADAPTER/DRAPE ISSUE. TSE INSTRUCTED THE SURGICAL STAFF TO REMOVE THE STERILE ADAPTER AND SPIN ALL FIVE DIALS AND THEN RE-INSTALL THE STERILE ADAPTOR AND ENDOSCOPE TO SEE IF THAT FIXES THE ISSUE. IF THAT DOESN'T FIX ISSUE, STAFF CAN TRY RE-DRAPING ARM 2. STAFF IS PROCEEDING WITH THE CASE AS IS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ARM2 WAS DISABLED AND THE ISSUE HAS NOT REOCCURRED. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821992 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES