BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15415197 · Received September 13, 2022

    Report

    Report Number
    2955842-2022-13976
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 15, 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
    OH, 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 COMPLAINT. THE FSE REPLACED THE VIDEO PROCESSOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE FIELD SERVICE ENGINEER (FSE) OBSERVED MASTER SUPERVISORY CONTROLLER (MSC) REPORTED A HARDWARE FAULT IN THE WHEEL COMMUNICATION. POINTING TO REAR CORE FIBER PORT (BOTTOM PORT). THE MSC NODE REPORTED THAT THE COORDINATOR'S FAULT RECOVERY SEQUENCE DID NOT COMPLETE. SOFTWARE RELEASE VERSION ON THE CORE DOES NOT MATCH THE VIDEO PROCESSOR (VP). RESOLVED WITH GEMINI DOWNLOAD APPLICATION (GDLA). THE SYSTEM POWERED UP NORMALLY DURING INSPECTION, BUT DUE TO ERRORS SEEN IN LOGS THE VP UNIT WAS REPLACED. SYSTEM READY FOR USE. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE WAS CONFIRMED. THE VIDEO PROCESSOR (VP) WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE VP FAILED WITH ERRORS 31030, 319. THE VIDEO CAMERA INTERFACE (VCI) NODES ON THE DUAL WINDOW APPLIANCE (DWA) BOARD WERE NOT PRESENT ON THE GEMINI LAPTOP APP. THE DWA BOARD HAD FAILED. NO IMAGES OR VIDEOS WERE SUBMITTED FOR REVIEW. A REVIEW OF THE PROCEDURE LOG SHOWED A PROSTATECTOMYRADICAL W/ PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2022 USING SYSTEM SK2043, MATCHING THE DOCUMENTED EVENT DETAILS. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO A BACKUP VISION SIDE CART AFTER THE START OF THE PROCEDURE DUE TO NON-RECOVERABLE FAULTS OCCURRING. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN IS NOT AVAILABLE. FIELD IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, AND H2. ANALYSIS INFORMATION CAN BE FOUND IN FIELDS H6 AND H10. THE VIDEO PROCESSOR (VP) UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE WAS REPLICATED. THE VP WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE VP FAILED THE SYSTEM TEST WITH ERROR 31004, THE UCC BOARD 653080-07 HAD FAILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER HAD A NON-RECOVERABLE FAULT ERROR AFTER MOVING THE SYSTEM. THE CUSTOMER ATTEMPTED TO POWER OFF THE SYSTEM WITHOUT RESOLVE. THE SYSTEM WAS HARD POWER CYCLED, AND THE ISSUE PERSISTED. LIVE LOGS WERE REVIEWED WHICH SHOWED THAT THE VIDEO PROCESSOR HAD A DIFFERENT SOFTWARE REVISION. ALL CONNECTIONS ON THE VIDEO PROCESSOR AND CORE WERE CHECKED AND CONFIRMED. THE SYSTEM WAS HARD POWER CYCLED AN AGAIN AND THE FAULT REMAINED. THE INTUITIVE SURGICAL, INC. (ISI) TECH SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO USE A SPARE VISION SIDE CART (VSC) FROM A SEPARATE SYSTEM. THE SYSTEM STARTED UP NORMALLY USING THE SPARE VSC. THE CUSTOMER CONTINUED WITH THE PROCEDURE WITH NO REPORTED PATIENT 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.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2667660 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A 00886874110898

    Patients

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