BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 15433633 · Received September 15, 2022

    Report

    Report Number
    2955842-2022-13993
    Event Type
    Injury
    Date Received
    September 15, 2022
    Report Date
    August 17, 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
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENTS WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿A CONTEMPORARY CASE SERIES OF COMPLEX SURGICAL REPAIR OF SURGICAL/ENDOSCOPIC INJURIES TO THE ABDOMINAL URETER¿ OPERATIVE COMPLICATIONS INVOLVING SURGICAL PROCEDURES WERE NOTED. A NUMBER OF THE COMPLICATIONS REQUIRED MEDICAL/SURGICAL INTERVENTION. THE CAUSES OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A (B)(6) UROLOGY FOCUS ARTICLE TITLED, ¿A CONTEMPORARY CASE SERIES OF COMPLEX SURGICAL REPAIR OF SURGICAL/ENDOSCOPIC INJURIES TO THE ABDOMINAL URETER¿ (FICARRA, V., ROSSANESE, M., ET. AL., 2021)." THE ARTICLE CITES THE PURPOSE OF THE STUDY AS FOLLOWS: "TO REPORT THE ETIOLOGY, PERIOPERATIVE OUTCOMES, AND TREATMENT FAILURE RATE OF DIFFERENT RECONSTRUCTIVE SURGICAL INTERVENTIONS FOR IATROGENIC INJURIES TO THE ABDOMINAL (MID-URETER AND UPPER) URETER IN A CONTEMPORARY CASE SERIES." PER THE ARTICLE, STUDY DATA WAS RETROSPECTIVELY COLLECTED FROM JULY 2013 THROUGH APRIL 2019 WITH A TOTAL OF 19 PATIENTS. ALL SURGICAL PROCEDURES WERE PERFORMED BY A SENIOR SURGEON WITH EITHER AN OPEN OR A ROBOT-ASSISTED APPROACH. PER THE ARTICLE, THE FOLLOWING IS NOTED: "A ROBOT-ASSISTED APPROACH WAS USED IN ONLY 21% OF CASES INCLUDED IN THE PRESENT SERIES. ONLY FOUR (21.1%) PROCEDURES WERE PERFORMED ROBOTICALLY (TWO BOARI BLADDER FLAPS (2 OF 12 TOTAL), ONE URETEROURETEROSTOMY (1 OF 2 TOTAL), AND ONE PYELOURETEROPLASTY (1 OF 3 TOTAL)). IN THE STUDY¿S SERIES, BOARI BLADDER FLAP PROCEDURES WERE PERFORMED ROBOTICALLY IN TWO PATIENTS. THE SECOND (URETEROURETEROSTOMY) CASE WAS PERFORMED ROBOTICALLY IN A YOUNG (42-YEAR-OLD) WOMAN WITH A SHORT STENOSIS OF THE (LEFT) LUMBAR URETER DUE TO AN ENDOUROLOGICAL PROCEDURE FOR STONE (ENDOURETERAL LITHOTRIPSY). IN THIS CASE, NEAR-INFRARED FLUORESCENCE (WITH INDOCYANINE GREEN) WAS USED TO EVALUATE THE GOOD VASCULARIZATION OF THE END SEGMENTS OF THE URETER (STRICTURE OF THE MID-URETER WAS IDENTIFIED). NO INTRAOPERATIVE COMPLICATIONS AND BLOOD TRANSFUSION WERE RECORDED." FURTHERMORE, IT IS NOTED: ¿MAJOR COMPLICATIONS WERE REPRESENTED BY ONE CASE OF WOUND DEHISCENCE REQUIRING SURGICAL REVISION AND ONE CASE OF MYOCARDIAL INFARCTION REQUIRING ADMITTANCE TO INTENSIVE CARE UNIT AMONG PATIENTS WHO HAD UNDERGONE A BOARI BLADDER FLAP PROCEDURE. INTENSIVE CARE ADMISSION FOR SEPSIS WAS NECESSARY FOR THE PATIENT WHO UNDERWENT URETEROURETEROSTOMY AFTER INFECTED AORTIC PROSTHESIS REMOVAL.¿ INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS 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
    178013 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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