BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 17662940 · Received August 31, 2023

    Report

    Report Number
    2955842-2023-18145
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 9, 2023
    Report Date
    August 9, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE 30-DEGREE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE ENDOSCOPE ROTATION ISSUE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ROTATION ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE CUSTOMER WAS ADVISED BY ISI TSE FOR THE 30-DEGREE ENDOSCOPE TO BE REMOVED FROM THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND PRESS THE CLUTCH BUTTON TO CANCEL THE GUIDED TOOL CHANGE FUNCTION. THE ISI TSE ALSO ADVISED THE CUSTOMER TO ROTATE THE SHAFT OF THE ENDOSCOPE TO CONFIRM IF THE MOTION IS SMOOTH, AND TO REPLACE THE 30-DEGREE ENDOSCOPE IF IT WAS NEEDED TO RESOLVE THE REPORTED EVENT. A SECOND CALL THAT WAS MADE TO ISI TSE REVEALED THAT REPLACING THE 30-DEGREE ENDOSCOPE WAS REQUIRED DUE TO THE BASE BEING DIFFICULT TO ROTATE THE BASE ON THE DEFECTIVE ENDOSCOPE. NO SITE VISIT WAS CONDUCTED. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED.

    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 GASTRECTOMY TOTAL SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) OBSERVED THAT THE 30-DEGREE ENDOSCOPE IMAGE WAS UPSIDE DOWN, THE BASE DID NOT ROTATE AND WAS HARD. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SERVICE ENGINEER (TSE). THE CUSTOMER WAS ADVISED TO REMOVE THE ENDOSCOPE FROM THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND PRESS THE CLUTCH BUTTON TO CANCEL THE GUIDED TOOL CHANGE FUNCTION OR REMOVE THE ENDOSCOPE FROM THE USM, ROTATE THE SHAFT OF THE ENDOSCOPE TO CONFIRM IF THE MOTION IS SMOOTH. THE CUSTOMER WAS ALSO ADVISED TO REPLACE THE ENDOSCOPE IF NEEDED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CSR, CLARIFIED THAT THE REPORTED EVENT OCCURRED DURING OPERATIONAL TESTING AFTER THE BEGINNING GASTRECTOMY TOTAL SURGICAL PROCEDURE. IT WAS NOTED THAT THE IMAGE ON THE 30-DEGREE ENDOSCOPE WAS INVERTED BUT WAS ABLE TO MOVE FREELY WITH UNCONTROLLED MOTION. WHEN THE 30-DEGREE ENDOSCOPE WAS INSTALLED, THE ORIENTATION WAS DOWNWARD, AND THE DESIRED ORIENTATION WAS CONFIRMED BY THE SURGEON. THE INDICATION OF THE IMAGE ORIENTATION WAS DISPLAYED ON THE INDICATOR. THE CUSTOMER OBSERVED THAT THERE WAS A GAP BETWEEN THE INDICATOR AND THE ACTUAL ROTATION OF THE CAMERA. THE REPORTED EVENT DID NOT INVOLVE REVERSE CONTROL ON THE SYSTEM ARMS. THE CUSTOMER OBSERVED THAT THE 30-DEGREE ENDOSCOPE DISK WAS NOT MOVING SMOOTHLY. PRIOR TO THE REPORTED EVENT OCCURRING, THE CUSTOMER HAD ROTATED THE 30-DEGREE ENDOSCOPE MANUALLY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP 30-DEGREE ENDOSCOPE. THERE WAS NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124936 DA VINCI ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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