BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20218869 · Received September 14, 2024

    Report

    Report Number
    2955842-2024-19374
    Event Type
    Malfunction
    Date Received
    September 14, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 21, 2024
    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
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM ISSUE WAS RESOLVED. CUSTOMER STATED THAT NO FURTHER TROUBLESHOOTING WAS PERFORMED, AND CASE WAS COMPLETED USING THE 0-DEGREE ENDOSCOPE. CUSTOMER WILL MONITOR AND FOLLOW UP IF ISSUE REOCCURS IN THE FUTURE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED. ISI HAS NOT RECEIVED THE 30-DEGREE ENDOSCOPE FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ,

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO FLIP THE 30-DEGREE ENDOSCOPE FROM THE CAMERA OR SURGEON CONSOLE. THE CUSTOMER HAD RESEATED THE ENDOSCOPE AND STERILE ADAPTER WITH NO CHANGE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED TO RESEAT INSTRUMENT AND ADAPTER AGAIN AND TO CANCEL GUIDED TOOL CHANGE. CUSTOMER INFORMED THEY WERE USING A 0-DEGREE ENDOSCOPE AND WILL TRY THAT LATER. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS USING THE ENDOSCOPE ON A DOWN POSITION WHEN THE ISSUE OCCURRED. HE GOT FRUSTRATED AND RUSHED THE CASE TO FINISH WITHOUT TRYING TO TROUBLESHOOT IN ANY WAY. NO INFORMATION ON SCOPE WAS TAKEN. SINCE THE EVENT, ALL 30-DEGREE ENDOSCOPES WERE WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113248 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-11 N/A 00886874116555

    Patients

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