BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16255064 · Received January 27, 2023

    Report

    Report Number
    2955842-2023-10364
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    January 5, 2023
    Report Date
    January 5, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING COLOR ON THE HRSV LEFT IMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE TSE HAD THE CUSTOMER POWER CYCLE THE SYSTEM, WHICH RESOLVED THE ISSUE. HOWEVER, THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO LAPAROSCOPIC SURGERY AFTER THE START OF THE PROCEDURE DUE TO HIGH-RESOLUTION STEREO VIEWER (HRSV) COLOR ISSUE. THE CONVERSION RESULTED IN ADDITIONAL PORTS BEING CREATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE LEFT HIGH-RESOLUTION STEREO VIEWER (HRSV) HAD COLOR ISSUE. THE CUSTOMER REPLACED THE ENDOSCOPE, BUT THE ISSUE PERSISTED. THE SURGEON ELECTED TO CONVERT TO LAPAROSCOPIC SURGERY. THE TSE HAD THE CUSTOMER POWER CYCLE THE SYSTEM, AND THE HRSV BECAME NORMAL. 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 WITHOUT ERROR. ADDITIONAL PORTS HAVE BEEN ADDED TO CONVERT TO LAPAROSCOPIC SURGERY. THE PATIENT TOLERATED THE CHANGE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412756 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-14 N/A 00886874110744

    Patients

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