BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20495254 · Received October 21, 2024

    Report

    Report Number
    2955842-2024-20799
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    April 2, 2024
    Report Date
    September 24, 2024
    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
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO SPECIFIC INFORMATION REGARDING THE PROCEDURE SITE OR DATE WAS PROVIDED; THEREFORE, NO DA VINCI SYSTEM OR ACCESSORIES LOG FILES ARE AVAILABLE. CITATION: HAZEN SJA, VAN GEFFEN EGM, SLUCKIN TC, BEETS GL, BELGERS HJ, BORSTLAP WAA, CONSTEN ECJ, DEKKER JT, HOMPES R, TUYNMAN JB, VAN WESTREENEN HL, DE WILT JHW, TANIS PJ, KUSTERS M; DUTCH SNAPSHOT RESEARCH GROUP. LONG-TERM RESTORATION OF BOWEL CONTINUITY AFTER RECTAL CANCER RESECTION AND THE INFLUENCE OF SURGICAL TECHNIQUE: A NATIONWIDE CROSS-SECTIONAL STUDY. COLORECTAL DIS. 2024 JUN;26(6):1153-1165. DOI: 10.1111/CODI.17015. EPUB 2024 MAY 5. PMID: 38706109.

    Description of Event or Problem · 0

    DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES SEVERAL COMPLICATIONS WERE NOTED. IN THE ROBOT-ASSISTED LAPAROSCOPY (RATS) GROUP FOR TOTAL MESORECTAL EXCISION (TME) PROCEDURES, SEVERAL UNPLANNED, UNKNOWN, AND PROCEDURE-RELATED COMPLICATIONS WERE OBSERVED. AMONG THE REASONS FOR PERFORMING A HARTMANN PROCEDURE, 21% WERE UNPLANNED, AND 14% HAD UNKNOWN REASONS. THERE WERE 9 MULTI-VISCERAL RESECTIONS AND 4 CONVERSIONS TO OPEN SURGERY, AND INVOLVED RESECTION MARGINS WERE SEEN IN 9% OF CASES, WHICH WAS SIGNIFICANTLY HIGHER THAN IN OTHER GROUPS. THESE FINDINGS HIGHLIGHT A HIGHER RATE OF RESECTION MARGIN INVOLVEMENT AND OCCASIONAL UNPLANNED INTERVENTIONS WITHIN THE RATS GROUP. ADDITIONALLY, 52 PATIENTS EXPERIENCED AT LEAST ONE UNPLANNED READMISSION. THE PRIMARY CAUSES OF READMISSION INCLUDED DEHYDRATION IN 5 PATIENTS, ILEUS IN 12 PATIENTS, ABSCESS OR FISTULA (INTRA-ABDOMINAL OR PRESACRAL) IN 14 PATIENTS, ANASTOMOTIC LEAKAGE IN 4 PATIENTS, AND STOMA-RELATED COMPLICATIONS IN 4 PATIENTS. FURTHERMORE, 26 PATIENTS REQUIRED AN UNPLANNED CONSTRUCTION OF A STOMA. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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
    1930964 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES