BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 20988663 · Received December 20, 2024

    Report

    Report Number
    2955842-2024-23443
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    June 15, 2024
    Report Date
    December 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 OR DA VINCI SYSTEM IDENTIFIERS. 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: TUFANO, A.; CILIO, S.; SPENA, G.; IZZO, A.; CASTALDO, L.; GRIMALDI, G.; MUSCARIELLO, R.; FRANZESE, D.; QUARTO, G.; AUTORINO, R.; ET AL. UNILATERAL POST-CHEMOTHERAPY ROBOT-ASSISTED RETROPERITONEAL LYMPH NODE DISSECTION FOR STAGE II NON-SEMINOMATOUS GERM CELL TUMORS: SEXUAL AND REPRODUCTIVE OUTCOMES. CANCERS 2024, 16, 2231. HTTPS://DOI.ORG/10.3390/CANCERS16122231 SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THIS PATIENT. THE MEAN AGE OF THE GROUP IS 32 YEARS, AND THE GENDER OF THE PATIENTS WERE MALES, ACCORDING TO THE TYPE OF THE PROCEDURES. 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. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS 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. FIELD H4 IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    Description of Event or Problem · 0

    A LITERATURE DESCRIBED A STUDY AIMED TO EVALUATE SEXUAL AND REPRODUCTIVE OUTCOMES OF 22 PATIENTS FOLLOWING POST-CHEMOTHERAPY ROBOT-ASSISTED RETROPERITONEAL UNILATERAL LYMPH NODE DISSECTION (PC-RRPLND) FOR NON-SEMINOMATOUS GERM CELL TUMORS (NSGCTS) AT A HIGH-VOLUME CANCER CENTER. AMONG THE PATIENTS INCLUDED IN THE STUDY, AN INTRAOPERATIVE COMPLICATION (VENA CAVA INJURY) WAS RECORDED, WITHOUT NEEDING PERIOPERATIVE BLOOD TRANSFUSION. NONE OF THE PATIENTS EXPERIENCED LATE POST-OPERATIVE COMPLICATIONS. RETROGRADE EJACULATION IS CONFIRMED TO BE ONE OF THE MOST COMMON COMPLICATIONS OF PC-RRPLND. 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
    2147370 DA VINCI DA VINCI NAY INTUITIVE SURGICAL, INC UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES