BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 17093831 · Received June 8, 2023

    Report

    Report Number
    2955842-2023-16094
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    August 17, 2020
    Report Date
    August 17, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    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

    THE ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE REPORTED ISSUE. FSE CONFIRMED THERE WERE COMMUNICATION ISSUES ON ALL THREE SCOPES AND REPLACED THE ENDOSCOPE CONTROLLER (EC). THE EC WAS RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. FAILURE ANALYSIS COULD NOT REPRODUCE THE REPORTED ISSUE, BUT CONFIRMED THE COMMUNICATION ERRORS VIA A LOG REVIEW. FAILURE ANALYSIS INSTALLED THE EC AND TESTED ON A PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE SYSTEM STARTED UP WITHOUT ERRORS. THE IMAGE WAS SHARP AND CLEAR IN BOTH DISPLAYS. THE SCOPE WAS INSERTED AND UNPLUGGED MULTIPLE TIMES AND THERE WERE NO ISSUES WITH RECOGNITION. 10 POWER CYCLES WERE RUN AND ALL PASSED WITH A GOOD IMAGE. THE EC REMAINED IN THE TEST SYSTEM FOR TWO HOURS WHILE TESTING OTHER BOARD AND IT PERFORMED WITHOUT ANOMALIES. NO TROUBLE WAS FOUND WITH THE EC. THE LOGS CONTAINED MULTIPLE INSTANCES OF ERROR 48406, 48221, 48225, AND 48229. THE CAMERA INSTRUMENTS (ENDOSCOPES) HAVE BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE CAMERA INSTRUMENT RETURNED UNDER RMA# (B)(4) HAD THE FOLLOWING FINDINGS: FAILURE ANALYSIS CONFIRMED BUT DID NOT REPLICATE THE REPORTED ISSUE. THE CAMERA INSTRUMENT¿S OVER-TEMPERATURE SENSOR WAS FOUND TO HAVE TRIPPED BASED ON THE LOG REVIEW, BUT THE INSTRUMENT SUCCESSFULLY PASSED THE QUALITY ASSURANCE PROCEDURE (QAP) TESTS WHEN TESTED IN-HOUSE. THE FOLLOWING LOGS WERE FOUND IN THE LOG REVIEW: 48225 POWER FAILURE, 48216 CAMERA TEMPERATURE SENSING NOT RESPONDING, 48221 DCIB COMMUNICATION ERROR, 48229 POWER WARNING, 48401 CAMERA TEMPERATURE REACHED 43C, AND 48402 CAMERA TEMPERATURE REACHED 55C. ADDITIONAL UNRELATED FINDINGS: THE DISTAL WINDOW OF THE CAMERA INSTRUMENT WAS FOUND TO HAVE HARD-WATER STAINS. THE CAMERA INSTRUMENT RETURNED UNDER RMA# (B)(4) HAD THE FOLLOWING FINDINGS: FAILURE ANALYSIS DID NOT CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE CAMERA INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED INITIALIZATION WITH NO ISSUES. THE CAMERA PASSED ALL QAP TESTING. A REVIEW OF THE LOGS REVEALED MULTIPLE COMMUNICATION ERRORS (48221, AND 48406). ADDITIONAL FINDINGS NOT REPORTED BY THE SITE: THE DISTAL FIBERS WERE FOUND TO HAVE RESIDUAL SOIL. THE HOUSING WAS REMOVED AND CORROSION WAS FOUND ON THE CLAMPING PULLEYS. VISUAL INSPECTION OF THE CHASSIS FOUND A SECTION WITH DISCOLORATION AND DEFORMATION MEASURING APPROXIMATELY 0.775¿ X 0.372¿.

    Description of Event or Problem · 0

    IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED URETEROPLASTY PROCEDURE, THE CUSTOMER RECEIVED A "NO CAMERA DETECTED" MESSAGE WHEN CONNECTING THE CAMERA TO THE VISION SIDE CART. THE CUSTOMER TRIED A SECOND ENDOSCOPE BEFORE CALLING IN AND HAD THE SAME ISSUE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD CUSTOMER CLEAN THE CONTACTS ON THE SCOPE AND THE EC BUT PROBLEM PERSISTED. AN ISI TSE HAD THE CUSTOMER EMERGENCY POWER OFF (EPO) THE VISION SIDE CART BUT THE PROBLEM PERSISTED. THE ISI TSE HAD THE CUSTOMER TRY A 3RD SCOPE, WHICH WORKED NORMALLY. DURING FIELD SERVICE, AN ISI FSE WAS INFORMED THAT THE THIRD ENDOSCOPE REVERTED BACK TO COLOR BARS AFTER 5 MINUTES OF WORKING PROPERLY. THE CUSTOMER CONVERTED TO DA VINCI XI (MULTIPORT) TO COMPLETE THE PROCEDURE WITHOUT PATIENT INJURY. ISI FOLLOWED-UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER TRIED TROUBLESHOOTING THE ISSUE BY THEMSELVES WITHOUT CONTACTING TECH SUPPORT. THE CUSTOMER WOULD INSTALL AN ENDOSCOPE ON THE SYSTEM, IT WOULD WORK FOR A WHILE, AND THEN THE SYSTEM WOULD DISPLAY THE ERROR. THE CUSTOMER MENTIONED THAT THEY THOUGHT IT COULD HAVE BEEN A SYSTEM ISSUE AND ELECTED TO CONVERT TO AN XI SYSTEM. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY. THE INSTRUMENTS WERE INSPECTED PRIOR TO USE, HOWEVER NO ISSUES WERE IDENTIFIED. THE CUSTOMER MENTIONED THAT A FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND TESTED THE ENDOSCOPES IN QUESTION. THE FSE CONFIRMED THE ISSUE WITH THE ENDOSCOPES, BUT NOTED THAT THE ISSUE WAS CAUSED BY THE ENDOSCOPES ONLY AND THERE WAS NO ISSUE WITH THE SP SYSTEM. THE PROCEDURE WAS A URETEROPLASTY. PATIENT DEMOGRAPHIC, RELEVANT TESTING, AND MEDICAL HISTORY INFORMATION WAS REQUESTED, HOWEVER THE CUSTOMER WAS ONLY ABLE TO PROVIDE THE FOLLOWING: PATIENT WAS A 66 YEAR OLD FEMALE. THE PROCEDURE WAS COMPLETED VIA DA VINCI XI MULTI-PORT WITH NO REPORTED INJURY. ISI FOLLOWED-UP WITH A NURSE THAT WAS PRESENT FOR THE REPORTED EVENT AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON THE DA VINCI XI SURGICAL SYSTEM. WITH REGARD TO THE TIME OF THE REPORTED EVENT, THE NURSE INDICATED THAT THE REPORTED ISSUE OCCURRED TOWARDS THE VERY BEGINNING OF THE CASE. THE NURSE DID NOT RECALL IF PORTS WERE PLACED, BUT INDICATED THAT THEY WERE ABLE TO ROLL THE PATIENT INTO THE ROOM WITH THE XI WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434762 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-34 N/A 00886874114742

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES