BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22523585 · Received July 16, 2025

    Report

    Report Number
    2955842-2025-29330
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 18, 2025
    Report Date
    June 18, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE HAD TRIED TO CLEAN THE ENDOSCOPE BECAUSE THE IMAGE SEEMED OFF/APPEARED DISTORTED. DESPITE THE ISSUE, THERE WAS NO PATIENT HARM. ISI HAS RECEIVED THE ENDOSCOPE FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 0-DEGREE ENDOSCOPE PLUS FOR FAILURE ANALYSIS INVESTIGATION. THE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE FAIL THE FOCUS TEST. THE ENDOSCOPE FAILED FOCUS AT A WORKING DISTANCE ALL DISTANCES ON LEFT EYE. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE ENDOSCOPE WAS EVALUATED AND PLACED ON A DIAGNOSTIC TESTER OR EQUIVALENT FOR FUNCTIONAL TESTING. THE LIGHT LEAKAGE TEST OR EQUIVALENT WAS PERFORMED TO DETECT IF ANY IMAGE QUALITY DEFECT(S) WERE DETECTED I EITHER OR BOTH EYES. THE ENDOSCOPE WAS FOUND WITH AN ARTIFACT(S) IN RIGHT EYE. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CAB INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. VISUAL INSPECTION CONFIRMED. THE ENDOSCOPE WAS DISASSEMBLED AND THE CAMERA MODULE WAS VISUALLY INSPECTED AND PLACED ON AN INTERNAL TESTER AND FAILED. THE CAMERA MODULE FAILED MTF TEST. THE ENDOSCOPE WAS VISUALLY INSPECTED AND/OR PLACED ON IN-HOUSE SYSTEM AND DETECTED WITH A CAMERA MODULE ISSUE. THE ENDOSCOPE WAS DISASSEMBLED, AND CAMERA MODULE WAS VISUALLY INSPECTED FOR DAMAGE AND/OR PLACED ON A DIAGNOSTIC TESTER. THE CAMERA MODULE EXHIBITED LENS DETACHED. THE PROBABLE ROOT CAUSE OF THE IMAGE ISSUE IS ATTRIBUTED TO DAMAGE DURING USE OR IMPROPER HANDLING. ACCIDENTAL DROPS OF THE ENDOSCOPE, INADVERTENT COLLISIONS WITH HARD SURFACES, OR IMPROPER CLEANING DURING REPROCESSING CAN RESULT IN DAMAGED OPTICAL COMPONENTS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT THEY HAD NO ERRORS ON THE SYSTEM, BUT THE 0-DEGEE ENDOSCOPE PLUS IMAGE WAS OFF. THE CALLER STATED THE IMAGE CAUSED THE SURGEON TO FEEL DIZZY. TSE ADVISED THE CUSTOMER TO TRY A NEW ENDOSCOPE. THE CALLER STATED THEY WOULD TRY ANOTHER ENDOSCOPE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167938 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470056-08 N/A 00886874116562

    Patients

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