BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 15442895 · Received September 16, 2022

    Report

    Report Number
    2955842-2022-14044
    Event Type
    Death
    Date Received
    September 16, 2022
    Report Date
    August 18, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿LAPAROSCOPIC VERSUS ROBOTIC ADRENALECTOMY IN PHEOCHROMOCYTOMA PATIENTS,¿ IT IS NOTED THAT THERE WAS ONE PHEOCHROMOCYTOMA-RELATED DEATH IN THE ROBOTIC GROUP INVOLVING A PATIENT WHO DEVELOPED SYSTEMIC METASTASES. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER # (B)(6) FOR MDR SUBMISSION OF THE NON-DEATH RELATED COMPLICATIONS NOTED WITHIN THE RA GROUP. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT 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

    ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF SURGICAL ONCOLOGY ARTICLE TITLED, ¿LAPAROSCOPIC VERSUS ROBOTIC ADRENALECTOMY IN PHEOCHROMOCYTOMA PATIENTS¿ (ISIKTAS, G., AVCI, S., ET AL., 2022). STUDY DATA WAS RETROACTIVELY COLLECTED FROM MARCH 2000 THROUGH OCTOBER 2021 WITH A TOTAL OF 157 PATIENTS (RA: N=87, LA: N=70). THE PURPOSE OF THE STUDY WAS TO COMPARE PERIOPERATIVE OUTCOMES OF LAPAROSCOPIC ADRENALECTOMY (LA) VERSUS ROBOTIC ADRENALECTOMY (RA) FOR PHEOCHROMOCYTOMA. WITHIN THE JOURNAL ARTICLE, A CONVERSION INVOLVING A DA VINCI SURGICAL PROCEDURE IS NOTED. PER THE ARTICLE, THERE WAS ONE CONVERSION TO OPEN SURGERY IN THE RA GROUP DUE TO AN INABILITY TO OBTAIN ADEQUATE SURGICAL EXPOSURE AND MAKE PROGRESS DURING THE CASE. ADDITIONALLY, WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS OCCURRED IN 4 PATIENTS FROM THE RA GROUP. COMPLICATIONS INCLUDED URINARY TRACT INFECTIONS (N=2), PNEUMONIA (N=1) AND VOLUME OVERLOAD (N=1). PATIENTS WERE FOLLOWED UP FOR A MEDIAN OF 60 MONTHS. DURING THIS FOLLOW-UP, ONE PATIENT DEVELOPED A RECURRENCE INVOLVING THE OPPOSITE ADRENAL GLAND AND ANOTHER PATIENT HAD A MULTIFOCAL SYSTEMIC RECURRENCE IN THE ROBOTIC GROUP. THERE WAS ONE PHEOCHROMOCYTOMA-RELATED DEATH IN THE ROBOTIC GROUP INVOLVING A PATIENT WHO DEVELOPED SYSTEMIC METASTASES. FOR THE PATIENT REFERENCED IN THE ARTICLE WITH THE REPORTED CONVERSION TO OPEN IN THE RA GROUP, THE AUTHOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE DA VINCI SYSTEM AND THE SYSTEM WORKED WELL. THE AUTHOR EXPLAINED THAT IT WAS RELATED TO A TUMOR WITH INFILTRATION INTO SURROUNDING TISSUES MAKING THE PROGRESS DIFFICULT. PER THE AUTHOR, ¿SOMETIMES, WE HAVE DIFFICULT CASES IN CHALLENGING TUMORS AND PATIENTS.¿ THERE WAS NO REPORTED PATIENT HARM OR INJURY. PER THE AUTHOR, THERE WERE NO COMPLICATIONS AND NO ADVERSE EVENTS. ALSO, THE AUTHOR INDICATED THAT THERE WAS NO MALFUNCTION OF A DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123756 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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