BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14257327 · Received April 29, 2022

    Report

    Report Number
    2955842-2022-11358
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    March 31, 2022
    Report Date
    March 31, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE TECHNICAL SERVICE ENGINEER (TSE) ADVISED THE CLINICAL SALES REPRESENTATIVE (CSR) TO POWER CYCLE THE ERBE WHEN POSSIBLE. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE CSR WAS ABLE TO POWER CYCLE THE ERBE TO RESOLVE THE ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. EVENT VERIFICATION: THE TSE VERIFIED THE EVENT UPON TROUBLESHOOTING WITH THE CUSTOMER. RFE PROCEDURE REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: AN ABDOMINOPERINEAL RESECTION PROCEDURE WAS PERFORMED ON (B)(6) 2022 ON SYSTEM (B)(4). SYSTEM LOG REVIEW: 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: IESU ERROR: C-06 - SYSTEM ERROR. ACTIVATION REQUEST WITHOUT PARAMETER DATASET. IESU ERROR: M-18 - INTERNAL TIMEOUT (CPU & SENSORS MODULE DOES NEED TOO MUCH TIME TO ENTER "IDLE" STATE). IESU ERROR: M-11 - INTERNAL TIMEOUT (CPU & SENSORS MODULE DOES NEED TOO MUCH TIME TO ENTER "READY" STATE). THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE SYSTEM WAS IN AN UNACCEPTABLE STATE AFTER THE START OF THE PROCEDURE AS THE ERBE HAD REPEATED ERRORS. WHILE THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A BACKUP GENERATOR, THE REPORTED ISSUE COULD BE INDICATIVE OF A SYSTEM FUNCTIONALITY PROBLEM THAT RESULTS IN THE SYSTEM BEING IN AN UNACCEPTABLE STATE. 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 ABDOMINOPERINEAL RESECTION SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) NOTED THAT THE CUSTOMER ENCOUNTERED REPEATED ERRORS ON THE ERBE, ERRORS M-11, C-00 AND C-06. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE ERRORS. THE TSE RECOMMENDED TO POWER CYCLE THE ERBE. THE CSR WAS UNABLE TO POWER CYCLE THE GENERATOR AT THE TIME BUT STATED THEY WOULD DO SO WHEN ABLE. THE TSE DISCUSSED HOW TO CONNECT A FORCE TRIAD GENERATOR. THE PROCEDURE WAS COMPLETING 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
    1078011 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A 00886874110898

    Patients

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