BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20776443 · Received November 25, 2024

    Report

    Report Number
    2955842-2024-22340
    Event Type
    Injury
    Date Received
    November 25, 2024
    Date of Event
    October 29, 2024
    Report Date
    October 29, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATION: BÉCSI Á, HÜTTL A, KUBIK A, MOLNÁR P, NYIRÁDY P. KEZDETI TAPASZTALATAINK A ROBOTASSZISZTÁLT RÉSZLEGES NEPHRECTOMIÁVAL [INITIAL EXPERIENCES WITH ROBOT-ASSISTED PARTIAL NEPHRECTOMY]. ORV HETIL. 2024 JUN 30;165(26):997-1001. HUNGARIAN. DOI: 10.1556/650.2024.33067. PMID: 38944819. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENT. STUDY DEMOGRAPHICS IN THE ROBOTIC GROUP INCLUDED PATIENTS WITH A MEDIAN AGE OF 58 YEARS ; THE MAJORITY OF THE PATIENTS WERE MALES (56%) FIELD B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED. 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. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY THAT EVALUATED 78 PATIENTS WHO UNDERWENT ROBOTIC ASSISTED-PARTIAL NEPHRECTOMY IN A SINGLE INSTITUTION BETWEEN JUNE 2022 AND MARCH 2024. THE STUDY WAS TO EVALUATE THE SURGICAL PARAMETERS AND COMPLICATIONS, AND THE HISTOLOGICAL RESULTS OF THE REMOVED TUMORS. ONE OF THE PROCEDURES WAS CONVERTED TO A TOTAL NEPHRECTOMY DUE TO BLEEDING. THERE WAS NO INFORMATION ABOUT THE CAUSE OF THE BLEEDING OR THE BLOOD LOSS VOLUME. FOUR POST-OPERATIVE COMPLICATIONS WERE MENTIONED, WHERE 2 PATIENTS REQUIRED ANTIBIOTIC TREATMENT FOR THEIR INFECTION. TWO PATIENTS EXPERIENCED HEMATURIA 7-10 DAYS POST PROCEDURE AND UNDERWENT INTERVENTIONAL RADIOLOGICAL INTERVENTION (CLAVIEN-DINDO III). THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236125 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES