BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14727198 · Received June 17, 2022

    Report

    Report Number
    2955842-2022-12213
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 17, 2022
    Report Date
    May 17, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE ROBOTICS COORDINATOR VIA PHONE AND HELPED TO PLUG UP THE FORCE TRIAD AND CONNECT THE CABLES ASSOCIATED WITH THE SYSTEM. THE ROBOTICS COORDINATOR CONFIRMED THAT THE EXTERNAL GENERATOR WAS WORKING AND PROCEDURE WAS CONTINUED. THE FSE ORDERED A NEW ERBE GENERATOR TO THE CUSTOMER VIA FED EX. THE FSE WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. AN INTEGRATED ELECTRO SURGICAL UNIT PART ID 951300-03 SERIAL NUMBER (B)(4) WAS REPLACED TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS ABLE TO REPLICATED/CONFIRMED THE REPORTED COMPLAINT. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER FOR REPAIR. THE VISUAL INSPECTION SHOWS THE ERBE GENERATOR WAS IN GOOD CONDITION. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED COMPLAINTS INVOLVING THIS PRODUCT OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY A TECHNICAL SUPPORT ENGINEER (TSE). INVESTIGATION REVEALED THERE WERE MULTIPLE SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL LOG REVIEWS CONFIRMED THAT SYSTEM (B)(4) WAS USED ON (B)(6) 2022 FOR A HIATAL HERNIA PARAOESOPHAGEAL PROCEDURE. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE ELECTRO SURGICAL GENERATOR UNIT (ESU) WAS ABANDONED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY THIRD-PARTY ESU. 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 HIATAL HERNIA PARAESOPHAGEAL PROCEDURE, THE ROBOTICS COORDINATOR CALLED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER(TSE) AND REPORTED THAT THE CUSTOMER WAS GETTING A MESSAGE ON THE ERBE THAT ACTIVATION HAS BEEN INTERRUPTED DUE TO AN ERROR. AN ERROR C-01 WAS OBSERVED ON ERBE IN THE SYSTEM LOGS. THE TSE ADVISED THE CUSTOMER TO TROUBLESHOOT BY POWER CYCLING THE ERBE, BUT THE ISSUE WAS NOT RESOLVED. THE TSE ADVISED THE CUSTOMER TO CONNECT THE FORCE TRIAD GENERATOR WHICH WOULD BE DISCUSSED WITH SURGEON AND ASKED TO CALL BACK IF NEEDED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CSR MENTIONED THAT THE CSR WAS ON THE CALL ALONG WITH THE FIELD ENGINEER WHEN THE ISSUE HAPPENED AND HELPED THE ROBOTICS COORDINATOR TO PLUG THE FORCE TRIAD AND CABLES DURING THE PROCEDURE. THE ISSUE WAS THAT EVERY TIME THE SURGEON APPLIED THE ENERGY, THE ACTIVATION WAS INTERRUPTED. THE FORCE TRIAD GENERATOR WAS USED AND IT WORKED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS A PROCEDURE DELAY OF 20-29 MINUTES DUE TO TROUBLESHOOTING AS THEY WERE TRYING TO FIND THE WIRE TO USE FOR THE FORCE TRIAD . THE CSR ALSO MENTIONED THAT THIS IS THE SECOND TIME IN 3 WEEKS THE ERBE GENERATOR WAS REPLACED. ISI FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTICS COORDINATOR MENTIONED THAT THE THERE WAS A PROCEDURE DELAY OF 20 MINS. THE ISSUE DID NOT OCCUR AGAIN IN ANY PROCEDURE AFTER THE GENERATOR WAS REPLACED BY THE FSE. THERE WERE NO INJURY/HARM TO THE PATIENT. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE ARE AVAILABLE FOR ISI REVIEW. THE PATIENT DEMOGRAPHICS AND PRE-EXISTING MEDICAL CONDITION DETAILS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509200 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES