BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16971731 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14279
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 14, 2021
    Report Date
    April 14, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110683
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE REPORTED COMPLAINT WAS NOT REPRODUCED DURING FIELD EVALUATION. THE HIGH-RESOLUTION STEREO VIEWER (HRSV) MONITOR WAS REPLACED TO ADDRESS THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HRSV INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED DURING FAILURE ANALYSIS. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO COMPONENT FAILURE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE USER OBSERVED THAT THE LEFT SURGEON SIDE CONSOLE (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV) EYE WENT "BLACK." WITHOUT CALLING DA VINCI TECHNICAL SUPPORT FOR TROUBLESHOOTING ASSISTANCE AND EVALUATION AS PROPER TROUBLESHOOTING PER INTUITIVE SURGICAL, INC. (ISI) PROCEDURES, THE SURGEON ELECTED TO REPLACE THE SSC WITH ANOTHER TO CONTINUE WITH THE PROCEDURE. AT AN UNSPECIFIED TIME, THE CUSTOMER REPORTED THE ISSUE TO ISI AND RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). UPON VERIFICATION, TSE CONFIRMED THAT THE USER ALREADY SWITCHED TO ANOTHER SSC PRIOR TO SEEKING TROUBLESHOOTING ADVISE WITH ISI. ADDITIONALLY, TSE CONFIRMED THAT A SYSTEM CHECK PRIOR TO STARTING THE PROCEDURE WAS DONE AND FOUND NO ISSUE. TSE INSTRUCTED THE USER TO PERFORM FURTHER TROUBLESHOOTING BY RETESTING THE SYSTEM WITH THE REPLACED SSC THROUGH A SYSTEM POWER CYCLE AND MONITORING FOR ISSUE RECURRENCE WHEN CLINICALLY POSSIBLE. TSE EVALUATION IDENTIFIED NO OTHER ISSUE. THE USER COMPLETED THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. THE CUSTOMER CONTACTED TECHNICAL SUPPORT A SECOND TIME TO REPORT THAT THE PREVIOUSLY RECOMMENDED ISI TROUBLESHOOTING STEP WAS COMPLETED AND CONFIRMED THAT BOTH HRSV EYE ON THE REFERENCED SSC DISPLAYED GOOD AND PROPER IMAGE. THIS CONFIRMS THAT THE REPORTED SSC HRSV ISSUE CAN BE RESOLVED HAD THE USER PERFORMED PROPER TROUBLESHOOTING WITH ISI TSE AND REPLACING WITH ANOTHER SSC WAS NOT NECESSARY. ALTHOUGH THIS WAS NOTED, CUSTOMER ELECTED TO DISCONTINUE USING THE SSC. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS CONFIRMED THAT AFTER FOLLOWING THE TSE TROUBLESHOOTING ADVICE BOTH SSC HRSV EYE IMAGE ARE VERIFIED WITHOUT ISSUE. THE ISI TSE CONFIRMED THAT THE ISSUE COULD HAVE BEEN PROPERLY ADDRESSED IF PROPER TROUBLESHOOTING WAS FOLLOWED OR PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816340 DAVINCI SI SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380610-15 N/A 00886874110683

    Patients

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