BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 13529743 · Received February 14, 2022

    Report

    Report Number
    2955842-2022-10249
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    October 28, 2021
    Report Date
    January 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
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSES OF THE PATIENTS' OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION FROM THE AUTHOR OF A DEFICIENCY OF A DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENTS. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS WAS NOT POSSIBLE DUE TO LACK OF SYSTEM AND INSTRUMENT DETAIL, EVENT/PROCEDURE DATE, AND CONFIRMATION OF SITE LOCATION. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL OF KIDNEY CANCER AND VHL ARTICLE TITLED, ¿PREDICTING STRICT TRIFECTA OUTCOMES AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY: COMPARISON OF RENAL, PADUA, AND C-INDEX SCORES,¿ IT IS NOTED THAT A NUMBER OF THE PATIENTS EXPERIENCED POST-OPERATIVE COMPLICATIONS WHICH REQUIRED MEDICAL INTERVENTION. THE CAUSES OF THE POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION FROM THE AUTHOR OF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    INTUITIVE BECAME AWARE OF A JOURNAL OF KIDNEY CANCER AND VHL ARTICLE TITLED, ¿PREDICTING STRICT TRIFECTA OUTCOMES AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY: COMPARISON OF RENAL, PADUA, AND C-INDEX SCORES¿ (KARAMIK, K., AKTAS, Y. ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED. ¿ALL 91 RAPN OPERATIONS WERE CARRIED OUT BY TWO SURGEONS (MS AND MA) USING THE DA VINCI XI ROBOTIC SURGICAL SYSTEM (INTUITIVE SURGICAL, INC., SUNNYVALE, CA, USA). THE COMPLICATIONS INCLUDED HEMORRHAGE NECESSITATING BLOOD TRANSFUSION (N = 8), URINE LEAK NECESSITATING JJ URETERAL STENT PLACEMENT, AND ILEUS RESOLVED WITH MEDICAL THERAPY (N = 1).¿ INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENTS INCLUDED IN THE STUDY HAD UNDERGONE ROBOTIC PARTIAL NEPHRECTOMY PROCEDURES BETWEEN JUNE 2015 AND SEPTEMBER 2020. NO SPECIFIC PROCEDURE/EVENT DATES WERE PROVIDED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM/INSTRUMENT/ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURES THAT INVOLVED THE OPERATIVE COMPLICATIONS. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THERE WERE 10 POSTOPERATIVE COMPLICATIONS. URINOMA OCCURRED IN 1 PATIENT WHICH WAS RESOLVED BY PLACING A JJ STENT. ILEUS OCCURRED IN 1 PATIENT WHICH PASSED AFTER 2 DAYS OF NO ORAL INTAKE. IN 8 PATIENTS, HEMOGLOBIN DECREASED DUE TO BLEEDING AND ERYTHROCYTE SUSPENSION WAS INSERTED. ACCORDING TO THE AUTHOR, THE COMPLICATIONS MENTIONED ARE THE MOST COMMON COMPLICATIONS AFTER PARTIAL NEPHRECTOMY AND FURTHER EXPLAINED, "IT CANNOT BE ATTRIBUTED TO A SPECIFIC CAUSE. IT MAY OCCUR ON A PATIENT BASIS, DEPENDING ON THE DURATION OF THE OPERATION, DEPENDING ON THE SIZE OF THE TUMOR, AND POST-OPERATIVE MOBILIZATION PROBLEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845493 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-22 N/A

    Patients

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