BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 15832434 · Received November 21, 2022

    Report

    Report Number
    2955842-2022-15429
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 22, 2022
    Report Date
    October 22, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED DUAL CAMERA CONTROLLER (DOCO) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS REQUESTED THE DOCO INVOLVED WITH THIS COMPLAINT BE RETURNED BUT IT HAS NOT BEEN RECEIVED YET. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE FAILURE ANALYSIS EVALUATION AND IF ADDITIONAL INFORMATION IS RECEIVED. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. AN EVENT VERIFICATION CONFIRMED THE PROCEDURE WAS PERFORMED ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM (B)(4). THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER SWITCHED TO OPEN SURGERY DUE TO REPEATED RECOVERABLE FAULTS THAT RENDER THE DA VINCI SYSTEM IN A NOT ACCEPTABLE STATE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DUAL CAMERA CONTROLLER (DOCO) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED/REPLICATED THE CUSTOMER REPORTED COMPLAINT. PCA TECH WAS ABLE TO REPLICATE THE REPORTED PROBLEM BY INSTALLING THE DOCO INTO A SYSTEM AND TESTING. IT FAILED VIDEO OUT WITH FLICKERING. INSPECTION FOUND CONNECTOR ON THE DFI BOARD HAD CORROSION. FA WILL REPLACE DFI BOARD TO FIX THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) AND VISION SIDE CART (VSC) MONITOR VISION WAS FLICKERING. THE SYSTEM HAD ISSUES DURING MONOPOLAR AND BIPOLAR ENERGY USE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY DUE TO VISION FLICKERING IN THE SURGEON SIDE CONSOLE RIGHT SIDE MONITOR AND VISION CART MONITOR, CUSTOMER DIDN¿T PERFORMED TROUBLESHOOTING STEPS AND IMMEDIATELY PROCEDURE CONVERTED TO LAPAROSCOPY. THERE WAS NO PATIENT INJURY. THE CUSTOMER DID NOT PERFORM ANY TROUBLESHOOTING STEPS DURING PROCEDURE.

    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
    395711 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-09 N/A 00886874110874

    Patients

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