BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14550082 · Received May 31, 2022

    Report

    Report Number
    2955842-2022-11931
    Event Type
    Injury
    Date Received
    May 31, 2022
    Report Date
    May 2, 2022
    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
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE PATIENTS' REPORTED COMPLICATIONS, AFTER UNDERGOING A DA VINCI-ASSISTED TOTAL MESORECTAL EXCISION PROCEDURES, CANNOT BE DETERMINED OR IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿IS ROBOTIC DA VINCI XI® SUPERIOR TO THE DA VINCI SI® FOR SPHINCTER PRESERVING TOTAL MESORECTAL EXCISION? OUTCOMES IN 150 MID LOW RECTAL CANCER PATIENTS,¿ IT IS NOTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED TOTAL MESORECTAL EXCISION PROCEDURE, A NUMBER PATIENTS EXPERIENCED COMPLICATIONS OF ANASTOMOTIC LEAKS (GRADED I-II 5 (14.7%) AND III 2 (5.8%)). AT THIS TIME, THE ROOT CAUSES OF THE PATIENTS' COMPLICATIONS ASSOCIATED WITH THE DA VINCI XI GROUP ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE COMPLICATIONS. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER #(B)(6) FOR MDR SUBMISSION OF THE POSTOPERATIVE COMPLICATIONS ASSOCIATED WITH THE DA VINCI SI GROUP NOTED WITHIN THE JOURNAL ARTICLE.

    Description of Event or Problem · 0

    ON (B)(6) 022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿IS ROBOTIC DA VINCI XI® SUPERIOR TO THE DA VINCI SI® FOR SPHINCTER PRESERVING TOTAL MESORECTAL EXCISION? OUTCOMES IN 150 MID LOW RECTAL CANCER PATIENTS¿ (ALIYEV, V., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED. THIS OBSERVATIONAL STUDY SUMMARIZED THE COMPARISON OF THE XI DA VINCI SYSTEM TO THE SI DA VINCI SURGICAL SYSTEMS FOR TOTAL MESORECTAL EXCISION. A RETROSPECTIVE ANALYST WAS CONDUCTED TO DETERMINE THE SUPERIORITY BETWEEN THE ROBOTIC DA VINCI SI® (SI GROUP) AND DA VINCI XI® (XI GROUP) GENERATION IN PATIENTS WITH MID-LOW RECTAL CANCER. BETWEEN DECEMBER 2011 AND DECEMBER 2017, 88 PATIENTS WITH MID-LOW RECTAL CANCER WERE OPERATED ON USING THE DA VINCI SI ROBOTIC SYSTEM, AND FROM JANUARY 2018 TO MAY 2021, 62 PATIENTS WITH MID-LOW RECTAL CANCER WERE OPERATED ON USING THE DA VINCI XI ROBOTIC SYSTEM. DIVERTING ILEOSTOMY WAS CREATED IN 81 (92%) PATIENTS OF THE DA VINCI SI GROUP AND IN 58 (93.5%) PATIENTS OF THE DA VINCI XI GROUP PATIENTS. THE CLAVIEN¿DINDO CLASSIFICATION SYSTEM (I-IV) WAS USED TO CLASSIFY ADVERSE EVENTS. SEVEN PATIENTS (11.3%) IN THE DA VINCI XI GROUP HAD ANASTOMOTIC LEAKS, COMPARED TO FIVE PATIENTS (5.7%) IN THE DA VINCI SI GROUP. ANASTOMOTIC LEAKAGE RATES WERE HIGHER IN THE XI GROUP COMPARED WITH SI GROUP PATIENTS, BUT NOT STATISTICALLY SIGNIFICANT (11.3% VERSUS 5.7%, P=0.173). IT WAS ASSUMED THAT THIS WAS DUE TO THE LARGE NUMBER OF MALE PATIENTS IN THE XI GROUP. PER THE AUTHORS, THESE SURGICAL OUTCOMES/COMPLICATIONS WERE CONSIDERED TO BE NORMAL, REGARDLESS OF WHETHER THE PROCEDURE WAS ROBOTIC OR NOT BECAUSE OF THE "TECHNICAL FUTURES" OF THE DA VINCI SI SYSTEM AND THE DA VINCI XI SYSTEMS. DESPITE THE HIGH INCIDENCE OF MID-DISTAL RECTAL TUMORS AND MALE PATIENTS IN THE XI GROUP, THE OPERATION TIME IS SIGNIFICANTLY LESS COMPARED TO SI GROUP. THERE WAS NO REPORT OR ALLEGATION FROM THE JOURNAL ARTICLE AUTHORS OF A SPECIFIC DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713967 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES