BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 14790241 · Received June 23, 2022

    Report

    Report Number
    2955842-2022-12338
    Event Type
    Injury
    Date Received
    June 23, 2022
    Report Date
    May 22, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF THE DATE OF THIS REPORT, THE ACCESSORY HAS NOT BEEN RECEIVED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SENT. REVIEW OF THE SITE'S SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME AS THE EVENT DATE, AND SYSTEM INFORMATION ARE UNKNOWN. NO IMAGES OR VIDEOS WERE PROVIDED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING: AFTER A ROBOT-ASSISTED LAPAROSCOPIC RADICAL CYSTECTOMY PROCEDURE, THE PATIENT DEVELOPED A PSEUDOANEURYSM OF THE INFERIOR EPIGASTRIC ARTERY (IEA). THE COMPLICATION WAS DUE TO A THIRD-PARTY TROCAR. THE PSEUDOANEURYSM WAS INITIALLY DIAGNOSED BY CONTRAST-ENHANCED ULTRASOUND (CEUS); SUBSEQUENTLY, A COMPUTED TOMOGRAPHY (CT) SCAN AND AN ANGIOGRAPHY TEST WERE PERFORMED. THE COMPLICATION WAS SUCCESSFULLY TREATED WITH A RADIOLOGICAL EMBOLIZATION OF THE ARTERY AND THE PATIENT WAS REPORTED TO HAVE NO ADDITIONAL COMPLICATIONS. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    Description of Event or Problem · 0

    ON 22-APR-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF ULTRASOUND ARTICLE TITLED, ¿INFERIOR EPIGASTRIC ARTERY PSEUDOANEURYSM SECONDARY TO PORT PLACEMENT DURING A ROBOT-ASSISTED LAPAROSCOPIC RADICAL CYSTECTOMY.¿ PER THE CLINICAL ARTICLE, DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH BRICKER URETEROILEOCUTANEOSTOMY AND EXTENDED PELVIC LYMPH NODE DISSECTION, THE PATIENT DEVELOPED AN INFERIOR EPIGASTRIC ARTERY (IEA) PSEUDOANEURYSM SECONDARY TO AN 8-MILLIMETER (MM) PORT PLACEMENT. THE PRE-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO LYMPHOADENOMEGALY AND BILATERAL HYDRONEPHROSIS, AND NO OTHER LOCALIZATION THAN THE BLADDER. THE PSEUDOANEURYSM WAS INITIALLY DIAGNOSED POST-OPERATIVELY BY CONTRAST-ENHANCED ULTRASOUND (CEUS); SUBSEQUENTLY, A CT SCAN AND AN ANGIOGRAPHY TEST WERE PERFORMED. THE PSEUDOANEURYSM WAS THEN TREATED SUCCESSFULLY WITH COIL EMBOLIZATION OF THE INFERIOR EPIGASTRIC ARTERY. NO COMPLICATIONS OCCURRED DURING OR AFTER THE EMBOLIZATION PROCEDURE. ON 03-JUN-2020, IS OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR OF THE CLINICAL ARTICLE REGARDING THIS EVENT: "THERE WAS NO MALFUNCTION OF THE DA VINCI SYSTEM, THIS COMPLICATION CAN OCCUR DURING PORT PLACEMENT, DUE TO THE ANATOMY VARIATIONS THAT ARE QUITE COMMON FOR THE INFERIOR EPIGASTRIC ARTERY, FOR THESE REASONS NO CLAIM OR ALLEGATION WAS REPORTED. MOREOVER, DIAGNOSIS WAS MADE SEVERAL DAYS AFTER SURGERY.¿ ON 03-JUL-2020, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE ARTICLE AUTHOR: "IN THIS CASE THE PSEUDOANEURYSM OF THE INFERIOR EPIGASTRIC ARTERY, WHICH COURSE QUITE OFTEN VARIES, WAS DUE TO A LAPAROSCOPIC TROCAR INSERTION DURING A ROBOTIC PROCEDURE, BUT NOT DUE TO A DA VINCI TROCAR. FURTHERMORE, THE COMPLICATION APPEARED AND EVOLVED SEVERAL DAYS AFTER THE PATIENT DISCHARGE (AROUND 10 DAYS AFTER). THE COMPLICATION WAS SUCCESSFULLY TREATED WITH A RADIOLOGICAL EMBOLIZATION OF THE ARTERY AND THE PATIENT ACTUALLY HAS A EXCELLENT PERFORMANCE STATUS AND NO MORE PAIN OR SYMPTOMS OF THE PSEUNOANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454658 DA VINCI DA VINCI XI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES