BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20327377 · Received September 27, 2024

    Report

    Report Number
    2955842-2024-19945
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 5, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112205
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE CUSTOMER DENIED THE OCCURRENCE OF AN INVERTED IMAGE, FREE MOVEMENT OF THE ENDOSCOPE WITH UNCONTROLLED MOTION, OR REVERSED CONTROL ON THE SYSTEM ARMS. THE SURGEON CONFIRMED DESIRED ORIENTATION WHEN THE ENDOSCOPE WAS INSTALLED, HOWEVER, IT COULD NOT BE CONFIRMED IF AN INDICATION OF THE IMAGE ORIENTATION WAS PROVIDED TO THE USER VIA THE USER INTERFACE. THE ENDOSCOPE AND ENDOSCOPE'S ADAPTER/BASE WERE CONFIRMED TO BE ENGAGED/IN-SYNCH/ATTACHED. THE SURGEON STATED THAT THE IMAGE LOOKED LIKE THE IMAGE WAS OVERLAPPING OR CROSSED EYED. THE ENDOSCOPE END WAS REMOVED AND REPLACED, HOWEVER, THE CROSS-EYED IMAGE STILL APPEARED. THE ENDOSCOPE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. IN ADDITION, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE FAILED THE FOCUS TEST DUE TO POOR FOCUS AT ALL DISTANCES IN ONE OF THE EYES. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 0-DEGREE 8MM ENDOSCOPE WAS ANALYZED AND TESTED ON A SYSTEM OR EQUIVALENT AND FOUND TO FAIL THE FOCUS TEST. THE ENDOSCOPE FAILED FOCUS AT A WORKING DISTANCE IN WHICH THE TEST FAILED ON RIGHT EYE. THE ENDOSCOPE WAS VISUALLY INSPECTED AND/OR PLACED ON IN-HOUSE SYSTEM AND DETECTED WITH A CAMERA MODULE ISSUE. THE CAMERA MODULE EXHIBITED FRONT NEGATIVE LENS DETACHED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON STATED THE EYES ON THE 0-DEGREE ENDOSCOPE DID NOT MATCH UP IN THE SURGEON SIDE CONSOLE (SSC). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684424 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470026-64 N/A 00886874112205

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES