BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14782777 · Received June 22, 2022

    Report

    Report Number
    2955842-2022-12297
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    January 8, 2020
    Report Date
    July 1, 2020
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE AND TYPE OF CLAVIEN-DINDO 1 COMPLICATION SUSTAINED BY THE PATIENT IN CASE 3 ARE UNKNOWN. IT IS ALSO UNKNOWN WHY THE PATIENT WAS HOSPITALIZED FOR 7 DAYS. THERE WAS NO REPORT OR ALLEGATION OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. A SYSTEM LOG REVIEW CANNOT BE PERFORMED DUE TO LACK OF INFORMATION PROVIDED. THE SITE NAME, SURGEON NAME, SYSTEM INFORMATION, AND EVENT DATE ARE UNKNOWN. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: WITHIN THE TRANSLATIONAL ANDROLOGY AND UROLOGY ARTICLE TITLED, ¿RETROPERITONEAL SINGLE-SITE ROBOT-ASSISTED PARTIAL NEPHRECTOMY USING LAPSINGLE VISION ADVANCED ACCESS PLATFORM: INITIAL THREE CASE REPORTS,¿ IT IS NOTED ALLEGED THAT THE SURGERY WAS CONVERTED FROM A SINGLE SITE SURGERY TO A MULTIPORT OPERATION DUE TO LIMITED RETROPERITONEAL SPACE AND DIFFICULTY IN MANAGING UPPER POLE RENAL MASS. THE ESTIMATED BLOOD LOSS WAS 550 ML AND THE WARM ISCHEMIA TIME WAS 55 MINUTES DUE TO CONVERSION TO MULTIPORT CONVERSION. FURTHERMORE, THE HOSPITAL DURATION WAS REPORTEDLY 7 DAYS AND THE PATIENT EXPERIENCE AN UNSPECIFIED CLAVIEN-DINDO 1 COMPLICATION. THE CAUSE AND TYPE OF COMPLICATION IS UNKNOWN. ADDITIONALLY, IT IS UNKNOWN WHY THE PATIENT REQUIRED A 7 DAY HOSPITALIZATION. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A TRANSLATIONAL ANDROLOGY AND UROLOGY ARTICLE TITLED, ¿RETROPERITONEAL SINGLE-SITE ROBOT-ASSISTED PARTIAL NEPHRECTOMY USING LAPSINGLE VISION ADVANCED ACCESS PLATFORM: INITIAL THREE CASE REPORTS¿ (D. KEUN KIM, ET AL., 2020). THIS ARTICLE PROVIDES A CASE SERIES DESCRIBING THE ADVANTAGE AND DISADVANTAGE OF RETROPERITONEAL SINGLE-SITE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (R-SSRPN) USING THE DA VINCI XI SURGICAL SYSTEM AND LAPSINGLE VISION ADVANCED ACCESS PLATFORM. THREE PATIENTS UNDERWENT R-SSRPN DUE TO INCIDENTAL FINDINGS OF A RENAL MASS. WITHIN THE ARTICLE, IT IS NOTED IN CASE 3 THAT A 38-YEAR OLD MAN UNDERWENT A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY AND, ¿THERE WAS CONVERSION TO MULTIPORT RETROPERITONEAL ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RPN) DUE TO LIMITED RETROPERITONEAL SPACE BY OBESITY AND UPPER POLE LOCATION RENAL MASS.¿ ADDITIONALLY, IT WAS NOTED THAT THE ESTIMATED BLOOD LOSS WAS 550 ML AND ¿THE WARM ISCHEMIA TIME WAS 55 MINUTES DUE TO CONVERSION TO MULTIPORT CONVERSION.¿ HOSPITAL DURATION WAS REPORTEDLY 7 DAYS AND THE PATIENT EXPERIENCED AN UNSPECIFIED CLAVIEN-DINDO 1 COMPLICATION. ALSO, IT IS NOTED, ¿ONCOLOGICAL OUTCOME REVEALED THAT THE PATHOLOGY RESULT REVEALED PT1AN0M0 CLEAR CELL RENAL CELL CARCINOMA (ISUP GRADE III) WITH A NEGATIVE SURGICAL MARGIN (TABLE 2).¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290286 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES