BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 15601018 · Received October 13, 2022

    Report

    Report Number
    2955842-2022-14554
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 13, 2022
    Report Date
    September 13, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS NOT ABLE TO REPRODUCE THE FLICKERING IMAGES ON ALL MONITORS. HOWEVER, THE FSE CONFIRMED THAT THERE WAS ALMOST NO LIGHT WHEN CHECKING THE LIGHT INTENSITY OF THE ILLUMINATOR. THE FSE REPLACED THE LAMP MODULE WITH A SPARE AND THE ILLUMINATOR WAS TURNED ON AGAIN AND THE LIGHT INTENSITY WAS NORMAL. THE DEFECTIVE LAMP MODULE MAY CAUSE THE IMAGE TO FLICKER DUE TO FLICKERING LIGHT. THE SYSTEM WAS TESTED OPERATED WITHOUT ERROR AND VERIFIED AS READY FOR USE. THE AFFECTED LAMP MODULE (PART 950093) INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNING TO ISI FOR FURTHER INVESTIGATION. A REVIEW OF THE PROCEDURE LOG SHOWED THE SITE PERFORMED THIS RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE ON (B)(6)2022 VIA SYSTEM SH2016. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE IMAGES WERE FLICKERING DURING THE PROCEDURE. EVEN THOUGH THE FIELD SERVICE ENGINEER (FSE) WAS NOT ABLE TO REPRODUCE THE ISSUE, THE LAMP MODULE WAS REPLACED DUE TO LOW BRIGHTNESS. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED. 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/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTICED THE IMAGE ON ALL MONITORS BEGAN FLICKERING. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER PRESS THE "DEFAULT FACTORY SETTING" WITH NO CHANGE. THE TSE THEN HAD THE CUSTOMER PERFORM POWER CYCLE OF THE SYSTEM AND RESEAT THE CAMERA CABLE; HOWEVER, THE ISSUE PERSISTED. THE ISSUE WAS NOT ONLY THE SCOPE BUT ALSO THE CAMERA HEAD. THE CUSTOMER ALREADY COMPLETED PROCEDURE UNDER THIS CONDITION. NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT AFTER THE PROCEDURE, THEY BOOTED UP THE SYSTEM TO CHECK AND CONTACTED DVSTAT TO REPORT THE FLICKERING IMAGE THAT OCCURRED DURING THE PROCEDURE, A "CAMERA ARM NOT FREE TO MOVE" MESSAGE DISPLAYED. THERE WAS NO ERROR OCCURRED WITH THE FLICKING IMAGE ISSUE. THE LAMP MODULE WAS REPLACED AND DISCARDED AT THE HOSPITAL. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2567539 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-11 N/A 00886874110874

    Patients

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