BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 21845822 · Received April 15, 2025

    Report

    Report Number
    2955842-2025-14026
    Event Type
    Death
    Date Received
    April 15, 2025
    Date of Event
    May 1, 2024
    Report Date
    March 17, 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
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH REPORT REPRESENTS THE DA VINCI MULTIPORT (MP) REPORTED DEATHS. SEE SECTION H10 FOR THE ASSOCIATED DA VINCI SINGLE PORT (SP) DEATH REPORTS. AN INVESTIGATION COULD NOT BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATES OR DA VINCI SYSTEM IDENTIFIERS. THERE WERE NO DEVICE ISSUES DOCUMENTED IN THE ARTICLE. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THIS ARTICLE DISCUSSED A SERIES OF PATIENTS COMPARING MULTIPORT AND SINGLE PORT ROBOTIC SURGERY WHO UNDERWENT RADICAL CYSTECTOMY. THIS REPORT IS REGARDING A MULTIPORT PATIENT WHO DIED ON POST OPERATIVE DAY 2 SECONDARY TO SEVERE ACIDOSIS AND HYPOTENSION. NO INTRAOPERATIVE DETAILS ARE PROVIDED. HOW THEY DIED AND THE CIRCUMSTANCES WHICH LED TO THEIR DEATH IS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT. CITATION: FANG, A. M., HAYEK, O., KAYLOR, J. M., PEYTON, C. C., FERGUSON, J. E., NIX, J. W., & RAIS BAHRAMI, S. (2024). POSTOPERATIVE OUTCOMES AND ANALGESIC REQUIREMENTS OF SINGLE-PORT VS MULTIPORT ROBOTIC-ASSISTED RADICAL CYSTECTOMY. JOURNAL OF ENDOUROLOGY, 38(5), 438¿443. HTTPS://DOI.ORG/10.1089/END.2023.0553. SECTION A2 AGE: THE STUDY POPULATION AGE RANGE FOR DA VINCI MP WAS 67.0 +/- 9.4 YEARS. MEAN AGE 67 YEARS. SECTION A3 GENDER: THE STUDY POPULATION FOR DA VINCI MP WAS MALE - 41; FEMALE - 8. SECTION A4 WEIGHT: THE STUDY POPULATION FOR DA VINCIE MP WAS BMI OF 30.3+/-6.5 KG/M2. SECTION B3 EVENT DATE IS UNKNOWN. THE DATE REFLECTS THE DATE THE ARTICLE WAS PUBLISHED - MAY 2024.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY TO COMPARE THE OUTCOMES OF 96 PATIENTS UNDERGOING ROBOTIC-ASSISTED RADICAL CYSTECTOMY (RARC) WITH URINARY DIVERSION FOR BLADDER CANCER. THE STUDY AIMED TO EVALUATE THE POSTOPERATIVE OUTCOMES AND ANALGESIC REQUIREMENTS OF 47 SINGLE-PORT (SP) VS 49 MULTIPORT (MP) ROBOTIC-ASSISTED RADICAL CYSTECTOMY. THE STUDY REPORTED THAT IN THE MP COHORT, A MORTALITY WAS NOTED WITH THE PATIENT EXPIRING ON POSTOPERATIVE DAY 2 SECONDARY TO SEVERE ACIDOSIS AND HYPOTENSION. THE STUDY CONCLUDED THAT THE SP ROBOTIC PLATFORM OFFERS A SAFE ALTERNATIVE TO THE MP ROBOTIC PLATFORM IN PERFORMING RARC WITH URINARY DIVERSION. NO CLINICALLY SIGNIFICANT DIFFERENCE WAS DEMONSTRATED IN PERIOPERATIVE OR ONCOLOGIC OUTCOMES. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGED THAT ANY INTUITIVE PRODUCTS CAUSED OR CONTRIBUTED TO THE DEATHS. THE DESIGNATED AUTHOR CONTACT HAS NOT RESPONDED TO A REQUEST FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425510 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| D DA VINCI INSTRUMENTS AND ACCESSORIES