BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 15250824 · Received August 18, 2022

    Report

    Report Number
    2955842-2022-13509
    Event Type
    Injury
    Date Received
    August 18, 2022
    Report Date
    July 20, 2022
    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 Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW CANNOT BE CONDUCTED DUE TO LACK OF SYSTEM AND PROCEDURE DETAILS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE EUROPEAN UROLOGY OPEN SCIENCE JOURNAL ARTICLE TITLED, ¿RETZIUS-SPARING ROBOT-ASSISTED RADICAL PROSTATECTOMY IN HIGH-RISK PROSTATE CANCER PATIENTS: RESULTS WERE FROM A LARGE SINGLE-INSTITUTION SERIES," A NUMBER OF OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES WERE REPORTED. SOME OF THESE PATIENTS REQUIRED MEDICAL/SURGICAL INTERVENTION DUE TO THE OPERATIVE COMPLICATIONS. THE CAUSES OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    ON 20-JUL-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿RETZIUS-SPARING ROBOT-ASSISTED RADICAL PROSTATECTOMY IN HIGH-RISK PROSTATE CANCER PATIENTS: RESULTS WERE FROM A LARGE SINGLE-INSTITUTION SERIES¿ (DELL'OGLIO, P., TAPPERO, S., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED. A TOTAL OF 14 INTRA-OPERATIVE COMPLICATIONS WERE REPORTED IN 14 PATIENTS. INTRA-OPERATIVE COMPLICATIONS WERE AS FOLLOWS; 6 PATIENTS HAD INJURY OF THE EPIGASTRIC ARTERY DURING TROCAR POSITIONING, 3 PATIENTS HAD INJURY TO THE ILIAC VESSELS DURING LYMPH NODE DISSECTION (LND), 2 HAD INJURY OF THE URETER DURING LND, 1 PATIENT HAD COMPLETE DISSECTION OF THE LEFT OBTURATOR NERVE, 1 PATIENT HAD AN INJURY OF THE BLADDER NEARBY THE RIGHT URETERAL ORIFICE THAT REQUIRED DOUBLE J-STENT POSITIONING, AND 1 PATIENT HAD AN INJURY OF THE BLADDER BELOW THE BLADDER NECK. A TOTAL OF 52 POST-OPERATIVE COMPLICATIONS IN 44 PATIENTS WERE REPORTED. THE POST-OPERATIVE COMPLICATIONS INCLUDED THE FOLLOWING: 17 PROLONGED CATHETERIZATIONS DUE TO URETHROVESICAL LEAKAGE AT CYSTOGRAM, 7 URINARY TRACT INFECTIONS REQUIRING ANTIBIOTIC THERAPY, 1 PULMONARY THROMBOEMBOLISM, 3 CASES OF DEEP VENOUS THROMBOSIS, 19 LYMPHOCELES TREATED WITH PERCUTANEOUS DRAINAGE, 3 ACUTE URINARY RETENTIONS REQUIRING BLADDER CATHETERIZATION, 1 ABDOMINAL HAEMATOMA TREATED WITH EXPLORATIVE LAPAROTOMY AND REVISION OF THE URETHROVESICAL ANASTOMOSIS, AND 1 VIDEOLAPAROSCOPIC REMOVAL OF NEEDLE FRAGMENT IN PELVIC AREA. 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
    2370487 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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