BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20906088 · Received December 11, 2024

    Report

    Report Number
    2955842-2024-22982
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    June 26, 2024
    Report Date
    November 18, 2024
    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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATES OR THE DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. CITATION: MARIA CHRISTODOULOU, TARA PATTILACHAN, SHARONA B. ROSS, ALEXANDER ROSEMURGY, ISWANTO SUCANDY, A SINGLE INSTITUTION¿S EXPERIENCE WITH ROBOTIC RESECTIONS OF BILIARY TRACT CANCERS: AN ANALYSIS OF THE SHORT-TERM OUTCOMES AND LONG-TERM SURVIVAL, JOURNAL OF GASTROINTESTINAL SURGERY, VOLUME 28, ISSUE 9, 2024, PAGES 1498-1504, ISSN 1091-255X, HTTPS://DOI.ORG/10.1016/J.GASSUR.2024.06.021. IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, A GENERIC XI SYSTEM WAS REPORTED.

    Description of Event or Problem · 0

    A SINGLE SITE PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE THE FEASIBILITY AND SAFETY OF ROBOTIC RESECTIONS FOR VARIOUS TYPES OF BILIARY TRACT CANCERS, INCLUDING PERIHILAR CHOLANGIOCARCINOMA (PCCA), INTRAHEPATIC CHOLANGIOCARCINOMA (IHCC), AND GALLBLADDER CANCER (GBC), AND TO ANALYZE BOTH SHORT-TERM OUTCOMES AND LONG-TERM SURVIVAL FOLLOWING THE SURGERIES, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE STUDY OCCURRED FROM 2013 TO 2023 AND INCLUDED A TOTAL OF 100 PATIENTS. THE FIRST COHORT INCLUDED 27 PATIENTS WITH PCCA, THE SECOND COHORT COMPRISED 25 PATIENTS WITH GBC, AND THE THIRD COHORT CONSISTED OF 48 PATIENTS WITH IHCC. IN THE COMBINED COHORTS, THERE WERE 56 MALES AND 44 FEMALES WITH A MEDIAN AGE OF 70 AND MEDIAN BMI OF 29. THE ARTICLE NOTED INTRAOPERATIVE AND POST-OPERATIVE COMPLICATIONS. ONE CASE OF INTRAOPERATIVE COMPLICATIONS FROM INFERIOR VENA CAVA BLEEDING DURING POSTERIOR HEPATIC DISSECTION. ONE PATIENT EXPERIENCED PNEUMOTHORAX AFTER CENTRAL LINE ATTEMPTS, EFFECTIVELY RESOLVED WITH A CHEST TUBE IN INTERVENTIONAL RADIOLOGY. ONE PATIENT NEEDED A REOPERATION FOR AN INCARCERATED HERNIA AT THE SPECIMEN EXTRACTION SITE AND 1 BILIARY STRICTURE NECESSITATING AN ERCP POSTOPERATIVELY, LIKELY RELATED TO BILIARY ISCHEMIC INJURY AT THE LEVEL OF THE UPPER COMMON HEPATIC DUCT. TWO PATIENTS REQUIRED PERCUTANEOUS DRAIN PLACEMENTS FOR BILIARY LEAKS. ONE PATIENT DEVELOPED POSTOPERATIVE BLEEDING FROM THE LIVER SURFACE, NECESSITATING A 2-DAY INTENSIVE CARE UNIT STAY AS WELL AS BLOOD TRANSFUSIONS. ANOTHER PATIENT REQUIRED PERCUTANEOUS NEEDLE ASPIRATION FROM THE INTERVENTIONAL RADIOLOGY DEPARTMENT FOR A PERIHEPATIC FLUID COLLECTION. ADDITIONALLY, 2 PATIENTS DEVELOPED ACUTE KIDNEY INJURY TREATED WITH FLUID RESUSCITATION. ANOTHER PATIENT ENCOUNTERED SEPSIS FROM AN INTRA-ABDOMINAL INFECTED ABSCESS, WHICH WAS PROMPTLY MANAGED. THERE WERE ONLY 2 PATIENTS READMITTED WITHIN 30 DAYS IN THE HOSPITAL. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED NOR ANY ALLEGATIONS THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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
    2433660 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES