BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19985539 · Received August 14, 2024

    Report

    Report Number
    2955842-2024-18067
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    January 13, 2024
    Report Date
    July 17, 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
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. THERE IS INSUFFICIENT INFORMATION ON THE PROCEDURE DATE AND THUS A SYSTEM LOG WAS NOT AVAILABLE TO BE PERFORMED. THERE IS ALSO INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT THE PROCEDURE HAD COMPLICATION, AS DA VINCI XI SYSTEM WAS MENTIONED IN THE ARTICLE, THEREFORE, THE PRODUCT IS REPORTED AS GENERAL XI SYSTEM. SOURCE: MASSALA-YILA, E.F., ALI, M., YU, W. ET AL. EVALUATING BODY MASS INDEX¿S IMPACT ON DA VINCI ROBOTIC RECTAL CANCER SURGERY, A RETROSPECTIVE STUDY. J ROBOTIC SURG 18, 22 (2024). HTTPS://DOI.ORG/10.1007/S11701-023-01774-W.

    Description of Event or Problem · 0

    DURING A REVIEW OF A CLINICAL ARTICLE THAT ASSESSED THE IMPACT OF BODY MAX INDEX (BMI) ON POST-OPERATIVE COMPLICATIONS OF ROBOTIC ASSISTED SURGERIES, THE FOLLOWING COMPLICATIONS WERE MENTIONED. 119 PATIENTS UNDERWENT ROBOTIC-ASSISTED SURGERIES FOR RECTAL CANCER WERE REVIEWED RETROSPECTIVELY. THE OBESE (BMI >27.9KG/M2) GROUP HAD A LONGER TIME TO FLATUS AND A HIGHER RE-OPERATION RATE THAN OTHER GROUPS. THE OVERWEIGHT GROUP HAD A HIGHER ANASTOMOTIC FISTULA RATE THAN THE OBESE GROUP. OVERALL COMPLICATIONS SHOWED NO SIGNIFICANT DIFFERENCES AMONG BMI COHORTS. AMONG 119 PATIENTS, 12 PATIENTS DEVELOPED COMPLICATIONS. THE MOST COMMON COMPLICATIONS WERE FEVER, ANASTOMOTIC FISTULA, INCISION INFECTION, AND INTESTINAL OBSTRUCTION. ONE PATIENT HAD ANASTOMOTIC LEAKAGE, WHO WAS ALSO OVERWEIGHT (BMI BETWEEN 23.9 TO 27.9KG/M2). 6 PATIENTS WAS FOUND WITH ANASTOMOTIC FISTULA. NO INFORMATION REGARDING THE MEDICAL INTERVENTION REQUIRED FOR ALL OF THE COMPLICATIONS, BUT 6 PATIENTS REQUIRED RE-OPERATION. THERE WAS NO MENTION OF ANY DA VINCI DEVICE MALFUNCTIONED IN ANY OF THE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371962 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES