BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17015845 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14968
    Event Type
    Malfunction
    Date Received
    May 27, 2023
    Date of Event
    December 8, 2020
    Report Date
    December 8, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112755
    PMA / PMN Number
    K101077
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT WAS RETURNED AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT WILL NOT FOCUS. THE CAMERA APPEARS TO HAVE BEEN PROCESSED IN A MANNER INCONSISTENT WITH ITS LABELING, RESULTING IN LIQUID INGRESS, RESULTING IN CORROSION OF ELECTRICAL AND MECHANICAL PARTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED A DARK IMAGE. THE CUSTOMER RE-CALIBRATED THE 8.5MM ENDOSCOPE AND WERE STILL OBSERVING A VERY DARK AND FUZZY IMAGE. THE CUSTOMER SWAPPED FROM AN 8.5MM ENDOSCOPE TO A 12 MM ENDOSCOPE AND THE IMAGE REMAINED DARK. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER TO VERIFY THE LIGHT GUIDE CABLE WAS FULLY SEATED AND REMOVE THE ENDOSCOPE TO CHECK FOR MOISTURE ON THE FACE OF THE CAMERA HEAD. THE TSE ASKED THE CUSTOMER IF THEY HAD A BACKUP CAMERA HEAD, AND IT WAS NOTED THAT THE CUSTOMER DID NOT HAVE A BACKUP. THE TSE THEN ASKED THE CUSTOMER TO RESTORE THE FACTORY SETTINGS FROM THE VISION SIDE CART (VSC) TOUCHSCREEN MENU, HOWEVER THE IMAGE DID NOT IMPROVE. THE CUSTOMER WAS UNSURE IF THE SURGEON WOULD PROCEED ROBOTICALLY. THERE WAS NO REPORTED INJURY OR HARM. ISI FOLLOWED UP WITH THE SITES ROBOTIC COORDINATOR (ROCO) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROCO CONFIRMED THE REPORTED ISSUE OCCURRED DURING A ROBOTIC-ASSISTED BILATERAL INGUINAL HERNIA REPAIR PROCEDURE. IT WAS NOTED THAT THE SURGEON ELECTED TO CONVERT TO THE PROCEDURE TO LAPAROSCOPIC SURGERY AS THEY DID NOT HAVE A SPARE CAMERA HEAD. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY WITH NO REPORTED INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915523 NONE CAMERA HEAD ASSEMBLY, HD, GLENAIR NAY INTUITIVE SURGICAL, INC 655858-03 N/A 00886874112755

    Patients

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