BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 17023243 · Received May 30, 2023

    Report

    Report Number
    2955842-2023-15153
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 1, 2023
    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
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION GATHERED, THE CAUSES OF THE COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ARTICLE CITATION: JEONG, S.Y.; KIM, K.; RYU, J.W.; CHA, J.; PARK, S.T.; PARK, S.H. COMPARISON OF SURGICAL OUTCOMES OF ROBOTIC VERSUS CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY OF LARGE UTERUS WITH GYNECOLOGIC BENIGN DISEASE. J. PERS. MED. 2022, 12, 2042. AVAILABLE FROM: HTTPS:// DOI.ORG/10.3390/JPM12122042.

    Description of Event or Problem · 0

    DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI-ASSISTED ROBOTIC PROCEDURES TITLED, ¿COMPARISON OF SURGICAL OUTCOMES OF ROBOTIC VERSUS CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY OF LARGE UTERUS WITH GYNECOLOGIC BENIGN DISEASE¿ (JEONG, S.Y., ET AL., 2023) THE FOLLOWING EVENTS WERE REPORTED. AS PART OF A RETROSPECTIVE COHORT STUDY AT A SINGLE CENTER BETWEEN JANUARY 2014 AND JULY 2022, A TOTAL OF 397 PATIENTS (197 PATIENTS UNDERWENT ROBOTIC HYSTERECTOMY, 200 PATIENTS UNDERWENT CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY) WHO UNDERWENT MINIMALLY INVASIVE HYSTERECTOMY FOR BENIGN DISEASES WITH UTERINE SIZE EXCEEDING 250G WERE ENROLLED. INTRA-OPERATIVELY, SIX PATIENTS RECEIVED BLOOD TRANSFUSIONS AND 4 PATIENTS HAD URETERAL INJURY. POST-OPERATIVELY, 101 PATIENTS EXPERIENCED URINARY RETENTION WITH CATHETERIZATION WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 1. TRANSFUSION AND ANTIBIOTIC USE WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 2 AND WERE SEEN IN 16 PATIENTS. TWO PATIENTS HAD CLAVIEN-DINDO GRADE 3 POST-OPERATIVE COMPLICATIONS, WITH NO FURTHER DETAILS. THERE IS NO INFORMATION REGARDING THE MEDICAL INTERVENTIONS THAT WERE PERFORMED. INTUITIVE SURGICAL, INC, (ISI) MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728049 DA VINCI PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES