BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15179967 · Received August 5, 2022

    Report

    Report Number
    2955842-2022-13352
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 8, 2022
    Report Date
    July 8, 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
    AZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS ADDRESSED WITH PHONE SUPPORT. AN ISI TSE WAS CONTACTED AND ADVISED THE CUSTOMER SWAP THE ENDOSCOPE TO A DIFFERENT USM AND THE CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED. THE CUSTOMER THEN SWAPPED THE ENDOSCOPE TO THE ORIGINAL USM AND REPORTED THAT IT WAS WORKING NORMALLY AGAIN. AN ISI FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE SITE AND THE CUSTOMER CONFIRMED NO RECURRENCES OF THE ISSUE HAD OCCURRED SINCE TROUBLESHOOTING WITH THE TSE. SYSTEM LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: A BENIGN HYSTERECTOMY PROCEDURE WAS PERFORMED ON SYSTEM SK4826 ON (B)(6) 2022. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT MOVED WITH UNINTUITIVE MOTION (E.G. THE INSTRUMENT UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY). UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. 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 HYSTERECTOMY, BENIGN SURGICAL PROCEDURE, A CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT INSTRUMENTATION WAS MOVING IN THE OPPOSITE DIRECTION OF THE SURGEON'S COMMANDS. THE CUSTOMER STATED THAT THEY EXCHANGED THE 30° ENDOSCOPE, HOWEVER, THE ISSUE REMAINED. THE CUSTOMER ALSO ATTEMPTED TO RESEAT THE STERILE ADAPTER, RESEAT THE ENDOSCOPE, AND RESTART THE SYSTEM WITH NO RESOLVE. THE TSE REVIEWED THE SYSTEM LOGS AND WAS UNABLE TO CONFIRM ANY RELATED ERROR MESSAGES. THE TSE RECOMMENDED THE CUSTOMER SWAP THE ENDOSCOPE TO A DIFFERENT UNIVERSAL SURGICAL MANIPULATOR (USM) AND THE CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED. THE CUSTOMER THEN SWAPPED THE BACKUP ENDOSCOPE TO THE ORIGINAL USM AND REPORTED THAT IT WAS WORKING NORMALLY AGAIN. THE PROCEDURE CONTINUED AS PLANNED WITH NO REPORTED INJURY. 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
    2517996 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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