BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 14941415 · Received July 7, 2022

    Report

    Report Number
    2955842-2022-12796
    Event Type
    Injury
    Date Received
    July 7, 2022
    Report Date
    June 6, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE ARTICLE CANNOT BE DETERMINED OR ARE UNKNOWN. 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. THE SPECIFIC PROCEDURE/EVENT DATES AND DA VINCI SYSTEM SERIAL #S ARE UNKNOWN. A REVIEW OF AN IMAGE IN THE ARTICLE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOPMENT ENGINEER (CDE). PER THE CDE, THE FOLLOWING WAS NOTED: INSIGHT RELATED TO THE NOTED INTRAOPERATIVE COMPLICATIONS FROM THESE IMAGES CANNOT BE PROVIDED. ANASTOMOTIC LEAKS AND PORT-SITE INFECTIONS ARE COMMON SURGICAL COMPLICATIONS AND ARE NOT UNIQUE TO INTUITIVE PRODUCTS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿SINGLE PLUS ONE-PORT ROBOTIC SURGERY USING THE DA VINCI SINGLE-SITE PLATFORM VERSUS CONVENTIONAL MULTI-PORT LAPAROSCOPIC SURGERY FOR LEFT-SIDED COLON CANCER,¿ MULTIPLE OPERATIVE COMPLICATIONS WERE NOTED INVOLVING PATIENTS WHO HAD UNDERGONE DA VINCI-ASSISTED SURGICAL PROCEDURES. IT IS UNCLEAR IF ANY MEDICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATIONS. THE CAUSES OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A VIDEOSURGERY AND OTHER MINIMALLY INVASIVE TECHNIQUES ARTICLE TITLED, ¿SINGLE PLUS ONE-PORT ROBOTIC SURGERY USING THE DA VINCI SINGLE-SITE PLATFORM VERSUS CONVENTIONAL MULTI-PORT LAPAROSCOPIC SURGERY FOR LEFT-SIDED COLON CANCER¿ (BAE, S. U., JEGON, W. K. AND BAEK, S. K., 2022). THE STUDY COMPARES THE CLINICAL AND COSMETIC OUTCOMES OF SINGLE PLUS ONE-PORT ROBOTIC SURGERY (SPORS) WITH THOSE OF MULTI-PORT LAPAROSCOPIC SURGERY (MPLS),WHICH IS PRESENTLY THE STANDARD SURGICAL TREATMENT FOR COLON CANCER. THE STUDY INCLUDED 36 PATIENTS WHO UNDERWENT SPORS AND 61 PATIENTS WHO UNDERWENT MPLS FOR LEFT-SIDED COLON CANCER BETWEEN AUGUST 2014 AND JANUARY 2016. WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED: TWO PATIENTS IN THE SPORS GROUP DEVELOPED A SUPERFICIAL SURGICAL SITE INFECTION AT THE SPECIMEN EXTRACTION SITE. ONE INSTANCE OF POSTOPERATIVE ANASTOMOTIC SITE BLEEDING OCCURRED IN THE SPORS GROUP, BUT REOPERATION OR ANOTHER INTERVENTION WAS NOT REQUIRED. ADDITIONALLY, IN THE SPORS GROUP, THERE WAS ONE CASE OF POST-OPERATIVE ILEUS AND TWO CASES OF POST-OPERATIVE PSEUDOMEMBRANOUS COLITIS. ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723861 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-40 N/A

    Patients

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