BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 17398901 · Received July 26, 2023

    Report

    Report Number
    2955842-2023-17324
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    June 27, 2023
    Report Date
    June 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112205
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ENDOSCOPE LEFT EYE BLUR, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE A CAMERA MODULE ISSUE. THE CAMERA MODULE EXHIBITED POOR FOCUS AT 140MM LEFT EYE. THE ENDOSCOPE WAS DISASSEMBLED, AND CAMERA MODULE WAS VISUALLY INSPECTED FOR DAMAGE AND/OR PLACED ON A DIAGNOSTIC TESTER. THE CAMERA MODULE EXHIBITED A FRONT (NEGATIVE) LENS DETACHED. ALSO, THE ENDOSCOPE WAS VISUALLY INSPECTED AND MANUALLY TESTED BY HAND, USING A SERIES OF MOVEMENT TESTS AND FAILED. THE ENDOSCOPE WAS DETECTED WITH RATTLING OR NOISE FROM THE HOUSING AND/OR DETECTED LOOSE BALLS FROM THE LED WINDOWS. A DISLODGED DESICCANT BALL INSIDE THE BACKEND HOUSING WAS CONFIRMED. MOREOVER, THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE CAUSE OF THE IMAGE ISSUE IS TYPICALLY 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.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A SCOPE LEFT EYE BLUR, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 0-DEGREE ENDOSCOPE. HOWEVER, AS OF THE DATE OF THIS REPORT, THE FAILURE ANALYSIS EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER EVALUATION OF THE DEVICE HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) FOR MDR SUBMISSION OF THE SAME EVENT REPORTED AGAINST THE OTHER ENDOSCOPE.

    Description of Event or Problem · 0

    REFER TO H10/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 CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AFTER DOCKING DUE TO THE LEFT EYE ON A 0-DEGREE ENDOSCOPE BEING BLURRY. THE CUSTOMER TRIED TO TROUBLESHOOT BY REPLACING THE ENDOSCOPE, BUT THE IMAGE WAS STILL BLURRED. THE TSE HAD THE CUSTOMER POWER CYCLE AND HARD CYCLE THE VISION SIDE CART (VSC) BUT THE IMAGE WAS STILL NOT COMING UP NORMALLY. THE TSE HAD THE CUSTOMER VERIFY THE IMAGE WAS BAD ON THE VSC AS WELL AS ON THE SURGEON SIDE CART (SSC). THE SURGEON OPTED TO CANCEL THE CASE. THERE WAS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: PATIENT WAS FINE. THERE WERE NO COMPLICATIONS OR PATIENT INJURY POST-ANESTHESIA. THEY JUST HAD TO WAKE UP THE PATIENT AS THERE WAS NO SCOPE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840613 DA VINCI ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470026-62 N/A 00886874112205

    Patients

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