BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14628474 · Received June 7, 2022

    Report

    Report Number
    2955842-2022-12058
    Event Type
    Injury
    Date Received
    June 7, 2022
    Report Date
    May 10, 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
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE PATIENTS' REPORTED OPERATIVE COMPLICATIONS/OUTCOMES CANNOT BE DETERMINED OR ARE 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. THERE WAS NO IMAGE OR VIDEO CLIP SUPPLIED FOR REVIEW RELATED TO A SPECIFIC EVENT. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿LAPAROSCOPIC VERSUS ROBOTIC-ASSISTED, LEFT-SIDED COLECTOMIES: INTRA- AND POSTOPERATIVE OUTCOMES OF 683 PATIENTS," A NUMBER OF COMPLICATIONS INVOLVING DA VINCI-ASSISTED LEFT-SIDED COLECTOMY PROCEDURES WERE NOTED. THE COMPLICATIONS/OUTCOMES INCLUDED THE FOLLOWING: ONE PATIENT EXPERIENCED INTRA-OPERATIVE BLEEDING, THREE PATIENTS UNDERWENT CONVERSIONS TO OPEN SURGERY, ONE PATIENT HAD A STOMA FORMATION, FIVE PATIENTS REQUIRED BLOOD TRANSFUSIONS, AND ICU WAS REQUIRED FOR 46 PATIENTS. THE CAUSES OF THE OPERATIVE COMPLICATIONS/OUTCOMES ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER #(B)(6) FOR MDR SUBMISSION OF THE POST-OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. ALTHOUGH THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A SURGICAL ENDOSCOPY JOURNAL ARTICLE TITLED, ¿LAPAROSCOPIC VERSUS ROBOTIC-ASSISTED, LEFT-SIDED COLECTOMIES: INTRA- AND POSTOPERATIVE OUTCOMES OF 683 PATIENTS¿ (GASS, J. M., DAUME, D., ET AL., 2022). THE PURPOSE OF THE STUDY WAS TO EVALUATE INTRA- AND POSTOPERATIVE RESULTS OF ROBOTIC-ASSISTED LAPAROSCOPY (RAL) COMPARED TO LAPAROSCOPIC (LSC) SURGERY IN LEFT-SIDED COLECTOMIES. FOR THE STUDY, INTRA- AND POSTOPERATIVE OUTCOME PARAMETERS WERE COLLECTED AND ANALYZED FOR 683 PATIENTS WHO UNDERWENT MINIMALLY INVASIVE LEFT-SIDED COLECTOMIES IN 2 INSTITUTIONS BETWEEN JUNE 2015 AND DECEMBER 2019. FOR THE ANASTOMOSES, LINEAR AND CIRCULAR STAPLING DEVICES WERE USED VIA THE DOUBLE-STAPLING TECHNIQUE. ADDITIONALLY, THE DA VINCI SI AND XI SURGICAL SYSTEMS WERE USED FOR THE RAL PROCEDURES. WITHIN THE JOURNAL ARTICLE, THE FOLLOWING OPERATIVE COMPLICATIONS/OUTCOMES INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: 1 INTRA-OPERATIVE COMPLICATION (BLEEDING), 3 CONVERSIONS TO OPEN SURGERY, 1 STOMA FORMATION, 5 BLOOD TRANSFUSIONS, AND ICU WAS REQUIRED FOR 46 PATIENTS. ISI HAS REACHED OUT TO THE CORRESPONDING AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197440 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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