BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 13563022 · Received February 18, 2022

    Report

    Report Number
    2955842-2022-10287
    Event Type
    Injury
    Date Received
    February 18, 2022
    Report Date
    February 23, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED INTRAOPERATIVE COMPLICATIONS CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM AND INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALED NO ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: DURING UNSPECIFIED DA VINCI-ASSISTED GYNECOLOGICAL SURGICAL PROCEDURES, THE SURGEON REPORTED CONCERNS REGARDING SUBCUTANEOUS EMPHYSEMA WITH THE USE OF CONMED¿S AIRSEAL SYSTEM AND DA VINCI TROCARS. AT THIS TIME, THE ROOT CAUSE OF THE OF THE REPORTED COMPLICATIONS IS UNKNOWN. IN ADDITION, THE SEVERITY OF EACH COMPLICATION IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    ON 23-FEB-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON: THE SURGEON INDICATED THAT THERE WERE ABOUT 5 OR 6 PATIENTS RECENTLY THAT HE CAN RECALL THAT HAD ISSUES POST-OPERATIVELY. ONE HAD FACIAL EDEMA IN THE OCULAR AREA POST-OPERATIVELY AND ANOTHER PATIENT EXPERIENCED ISSUES IN THE UPPER CHEST IN WHICH SHE HAD TO STAY LONGER IN THE HOSPITAL FOR OBSERVATION. THE SURGEON EXPRESSED CONCERN ABOUT AIR GETTING UNDER THE DIAPHRAGM AND THE AIR ENTRAINMENT UNDER PRESSURE, INTRAABDOMINAL. THE SURGEON EXPLAINED THAT HE USES THE SUCTION ON THE SUCTION IRRIGATION DUE TO THE INTERACTION BETWEEN THE INSUFFLATION AND THE AIRSEAL, AND CONCERN WITH ROOM AIR AND THE ABILITY TO KEEP UP WITH THE INSUFFLATION AND FLOW RATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING UNSPECIFIED DA VINCI-ASSISTED GYNECOLOGICAL SURGICAL PROCEDURES ON RECENT PATIENTS, THE SURGEON EXPRESSED CONCERNS REGARDING SUBCUTANEOUS EMPHYSEMA WITH THE USE OF CONMED¿S AIRSEAL SYSTEM AND DA VINCI TROCARS. THE SURGEON HAS CONCERNS WITH LARGE PELVIC PROCEDURES IN REGARD TO PORT PLACEMENT, THE IMPACT ON THE INCISION, AND THE RISK OF CO2 AND O2 ENTERING RETRO-PERITONEAL INTO FASCIA OR SUBCUTANEOUS TISSUE. THE SURGEON USES THE SUCTION IRRIGATOR TO MINIMIZE SMOKE. HOWEVER, THE DESIGN OF THE AIRSEAL, ROOM AIR IS REQUIRED TO MAINTAIN THE SURGICAL DOMAIN. THE SURGEON ALSO REPORTS THE CONCERN OF ROOM AIR ENTERING THE SUBCUTANEOUS SPACE. INTUITIVE SURGICAL, INC (ISI) HAS REACHED OUT TO THE SURGEON TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16772 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-20 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES.