BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 16989349 · Received May 23, 2023

    Report

    Report Number
    2955842-2023-14517
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    April 28, 2023
    Report Date
    April 28, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT ENDOSCOPE HAD REVERSED MOVEMENT AND ORIENTATION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CSR AND WAS ADVISED THAT THE ISSUE WAS RESOLVED AFTER RESEATING THE ENDOSCOPE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE ENDOSCOPE MOVED WITH UNINTUITIVE MOTION. POOR CAMERA CONTROL COULD RESULT IN UNINTUITIVE MOTION AND SUBSEQUENT TISSUE DAMAGE. AT THIS TIME, THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE THAT THE ENDOSCOPE MOVEMENTS WERE REVERSED, 30 UP WAS DOWN AND DOWN WAS UP. THE INTUITIVE SURGICAL INC.(ISI) TECH SUPPORT ENGINEER (TSE) CHECKED THE LOGS AND FOUND COMMUNICATION ERRORS. THE TSE RECOMMENDED A SECOND ENDOSCOPE, BUT NO OTHER ENDOSCOPE WAS AVAILABLE. THE TSE THEN WALKED THE CLINICAL SALES REP (CSR) THROUGH REMOVING THE ENDOSCOPE MANUALLY AND ROTATING THE ENDOSCOPE TO THE PROPER ORIENTATION, AND PORT CLUTCHING TO CLEAR THE GUIDED TOOL CHANGE. DURING THESE STEPS, THE CSR HAD TO END THE CALL TO ASSIST THE STAFF. THE CSR STATED THEY WOULD HAVE THE STAFF COMPLETE THE STEPS AND WOULD CALL BACK IN IF THE ISSUE CONTINUED. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218868 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A

    Patients

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