BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17015860 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14985
    Event Type
    Malfunction
    Date Received
    May 27, 2023
    Date of Event
    February 12, 2021
    Report Date
    February 15, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112212
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 8MM ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FOCUS TESTING REVEALED VISION LOSS IN THE LEFT EYE AS NO IMAGE WAS DISPLAYED. THERE WAS NO TROUBLE FOUND IN THE RIGHT EYE. A RELATED FAILURE WAS OBSERVED - DURING INSPECTION OF THE BINDING, DAMAGE OR FRICTION OF THE ENDOSCOPE ADAPTER WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SURGEON CONVERTED TO LAPAROSCOPY DUE TO THE 8MM ENDOSCOPE IMAGE CHANGING COLORS AND FLICKERING. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM LOGS AND FOUND ERRORS 45311 AND 48229 ON THE ENDOSCOPE. THE SURGEON INSTALLED ANOTHER ENDOSCOPE AFTER THE CONVERSION AND THE NEW IMAGE WAS GOOD. THE ERROR WERE MESSAGES CLEARED WHEN THE ENDOSCOPE WAS INSTALLED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SITES ROBOTICS COORDINATOR (ROCO) CONFIRMED THEY HAD A CAMERA ISSUE AND THE SURGEON ELECTED TO DO THE CASE LAPAROSCOPICALLY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916407 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-65 N/A 00886874112212

    Patients

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