BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI

    MDR report key: 21667386 · Received March 21, 2025

    Report

    Report Number
    2955842-2025-10419
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    August 12, 2024
    Report Date
    February 26, 2025
    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

    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 AND PROCEDURE THAT HAD COMPLICATIONS; ONLY DA VINCI XI AND SI SYSTEM WERE MENTIONED IN THE ARTICLE WITHOUT THE SPECIFIC PRODUCT INFORMATION. THEREFORE, THE PRODUCT IS REPORTED AS NOT APPLICABLE. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. CITATION: MONSELLATO, I., GATTO, T., LODIN, M., SANGIUOLO, F., PALUCCI, M., DEL BASSO, C., GIANNONE, F., & PANARO, F. (2024). ROBOTIC SPLENIC FLEXURE CANCER RESECTION: TECHNIQUE AND SHORT-TERM OUTCOMES. MINERVA SURGERY. HTTPS://DOI.ORG/10.23736/S2724-5691.24.10477-7. HOUQIONG, J., YULI, Y., FUJIA, G., YAHANG, L., TAO, L., YANG, L., DONGNING, L., & TAIYUAN, L. (2024). THE MODIFIED SURGICAL APGAR SCORE PREDICTIVE VALUE FOR POSTOPERATIVE COMPLICATIONS AFTER ROBOTIC SURGERY FOR RECTAL CANCER. SURGICAL ENDOSCOPY, 38(10), 5657¿5667. HTTPS://DOI.ORG/10.1007/S00464-024-11089-Y.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE DESCRIBED AS A RETROSPECTIVE SINGLE-CENTER STUDY INCLUDED 524 PATIENTS WHO UNDERWENT ROBOTIC RADICAL RESECTION FOR RECTAL CANCER FROM JANUARY 2015 TO DECEMBER 2023. THE STUDY INCLUDED PATIENTS DIAGNOSED WITH RESECTABLE RECTAL CANCER WITHOUT DISTANT METASTASES. PATIENTS WITH INCOMPLETE MEDICAL RECORDS WERE EXCLUDED FROM THE STUDY. DURING A REVIEW OF A CLINICAL LITERATURE ARTICLE, IT WAS NOTED THAT DURING THESE DA VINCI (DV) SURGERIES, THE STUDY HIGHLIGHTS A SIGNIFICANT DIFFERENCE IN COMPLICATION RATES (P LESS THAN 0.001), WITH 17.4 PERCENT OF CASES EXPERIENCING ADVERSE EVENTS. BASED ON CLAVIEN¿DINDO CLASSIFICATION, 13.2 PERCENT HAD MINOR COMPLICATIONS (LESS THAN GRADE III), WHILE 4.2 PERCENT HAD SEVERE COMPLICATIONS (GREATER THAN OR EQUAL TO GRADE III, P = 0.014). NOTABLE COMPLICATIONS INCLUDED ANASTOMOTIC FISTULA (4.2 PERCENT), ILEUS (2.1 PERCENT), INFECTIONS (ABDOMINAL: 1.7 PERCENT, PULMONARY: 2.9 PERCENT, URINARY: 1.3 PERCENT), WOUND-RELATED ISSUES (2.3 PERCENT), DEEP VEIN THROMBOSIS (1.5 PERCENT), AND CARDIAC COMPLICATIONS (1.3 PERCENT). THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. 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
    1281813 DAVINCI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.