BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 14616728 · Received June 7, 2022

    Report

    Report Number
    2955842-2022-12042
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 28, 2018
    Report Date
    May 19, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: IN THE JOURNAL ARTICLE TITLED, "EARLY CLINICAL EXPERIENCES OF ROBOTIC ASSISTED AORTIC VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS WITH SUTURELESS AORTIC VALVE," IT IS NOTED THAT A PATIENT EXPERIENCED POST-OPERATIVE FLUID OVERLOAD DUE TO VASODILATATION AFTER UNDERGOING A DA VINCI-ASSISTED AVR PROCEDURE. AS A RESULT, THE PATIENT WAS TREATED WITH AGGRESSIVE DIURESIS. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED POST-OPERATIVE ATRIAL FIBRILLATION. NO MEDICATION FOR CONTROLLING RHYTHM WAS GIVEN. NO OTHER TREATMENT OR MEDICAL INTERVENTION WAS REPORTED. THE PATIENT WAS DISCHARGED DAYS 4 AND 10 POST-OPERATIVELY.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN INNOVATIONS JOURNAL ARTICLE TITLED, "EARLY CLINICAL EXPERIENCES OF ROBOTIC ASSISTED AORTIC VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS WITH SUTURELESS AORTIC VALVE¿ (NAGAOKA, E. ET. AL. 2020). IN THIS ARTICLE, STUDY DATA WAS RETROSPECTIVELY COLLECTED FROM 2 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED AORTIC VALVE REPLACEMENT (AVR) IN A SINGLE INSTITUTION BETWEEN MAY AND JUNE 2018. THERE WERE NO MAJOR COMPLICATIONS REPORTED AND NO CONVERSIONS TO STERNOTOMY. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: "ONE PATIENT HAD FLUID OVERLOAD POSTOPERATIVELY DUE TO VASODILATATION AND REQUIRED AGGRESSIVE DIURESIS. OTHERWISE, POSTOPERATIVE CONVALESCENCE WAS UNCOMPLICATED. THEY WERE DISCHARGED HOME AT DAYS 4 AND 10 AFTER OPERATION, DUE TO POSTOPERATIVE ATRIAL FIBRILLATION RESPECTIVELY (TABLE 3)." ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE ARTICLE: "THE POST-OPERATIVE OUTCOME WAS UNRELATED TO THE FUNCTION OF THE DA VINCI SYSTEM." HE FURTHER INDICATED THAT "THERE ARE NO SUCH ALLEGATIONS" THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE INVOLVING THE OPERATIVE COMPLICATION. ADDITIONALLY, THE AUTHOR INDICATED, "THERE ARE NO ALLEGATIONS THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE POST-OPERATIVE OUTCOME, SINCE IT WAS NOT A COMPLICATION." IN ADDITION, THE AUTHOR PROVIDED INFORMATION THAT A POST OPERATIVE REPORT WAS NOT AVAILABLE. THE POST-OPERATIVE ATRIAL FIBRILLATION WAS PRESENT PREOPERATIVELY. THE PATIENT RECEIVED DIURETICS FOR FLUID OVERLOAD. NO MEDICATION FOR CONTROLLING RHYTHM WAS GIVEN. HIS MEDICATIONS AT DISCHARGE INCLUDED EC ASA 81 MG OD, APIXABAN 5 MG BID (FOR POSTOPERATIVE ATRIAL FIBRILLATION), LASIX 20 MG OD, SLOW K 600 MG OD, LANSOPRAZOLE 30 MG OD, SERTRALINE 100 MG OD, EZETIMIBE 10 MG OD, SIMVASTATIN 5 MG MON/WED/FRI, LEVODOPA/CARBIDOPA 100 MG/25 MG QID, MOMETASONE NASAL SPRAY BID, PROSCAR 5 MG QHS, AND TYLENOL 325 MG 2 TABLETS Q6H PRN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123376 DA VINCI DA VINCI SI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES