BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 18107034 · Received November 9, 2023

    Report

    Report Number
    2955842-2023-19766
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    October 20, 2023
    Report Date
    October 23, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE NO FAILURE. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. ADDITIONAL OBSERVATION, NOT REPORTED BY THE CUSTOMER: CAMERA INSTRUMENT ADAPTER BEARING FRICTION ISSUE WAS NOTED. CORROSION ON IC ELECTRICAL CONTACTS, DISCOLORATION OF HOUSING AND TRANSMITTANCE TEST FAILURE WERE NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE UNIVERSAL SURGICAL MANIPULATOR (USM3) STOPPED WORKING. DURING THE TROUBLESHOOTING, THE USER DISABLED THE USM 3 BY THEMSELVES BECAUSE OF A RECOVERABLE FAULT 23003. IT WAS NOTED THAT THE CUSTOMER ENCOUNTERED AN IMAGE ORIENTATION ISSUE WITH THE ENDOSCOPE. AFTER THE REBOOT AND INSTALLING A NEW ENDOSCOPE, THE SYSTEM WORKED AS INTENDED. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE WAS MOVING WITH NON-INTUITIVE MOVEMENTS; IT WAS MOVING FREELY WITH UNCONTROLLED MOVEMENTS. THE PROBLEM WAS OCCURRING SPORADICALLY. THE CUSTOMER USED A SPARE ENDOSCOPE AND COMPLETED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111224 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