BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 13471400 · Received February 7, 2022

    Report

    Report Number
    2955842-2022-10188
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    September 3, 2020
    Report Date
    January 12, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THE FOLLOWING INVESTIGATIONS COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION PROVIDED (I.E. EVENT DATE): SITE COMPLAINT HISTORY REVIEW, EVENT VERIFICATION, SYSTEM/INSTRUMENT LOG REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT EIGHT PATIENTS EXPERIENCED COMPLICATIONS INVOLVED WITH A DA VINCI-ASSISTED HYSTERECTOMY. ONE PATIENT REQUIRED AN INTRA-OPERATIVE CONVERSION TO OPEN. SEVEN PATIENTS EXPERIENCED POST-OPERATIVE COMPLICATIONS WHICH REQUIRED MEDICATION TO RESOLVE.

    Description of Event or Problem · 0

    ON 12-JAN-2022, INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿SURGICAL OUTCOME FOR ROBOTIC-ASSISTED SINGLE-SITE HYSTERECTOMY (RSSH) IN FEMALE-TO MALE REASSIGNMENT COMPARED TO ITS USE IN BENIGN GYNECOLOGICAL DISEASE: A SINGLE CENTER EXPERIENCE¿ (GARDELLA, B., DOMINONI, M., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: ¿DURING THE ROBOTIC PROCEDURES, NO MECHANICAL PROBLEMS OR ADVERSE EVENTS RELATED TO THE USE OF ROBOTIC EQUIPMENT WERE REPORTED. WE COMPLETED A ROBOTIC SINGLE-SITE PROCEDURE IN ALL OF THE TRANSGENDER MEN (TM), WHILE IN ONLY 1 CISGENDER WOMAN (CW) WE NEEDED TO RESORT TO A LAPAROTOMY. ONE DINDO GRADE II COMPLICATION (BLADDER INJURY) WAS REPORTED IN THE CW GROUP, WHILE NO INTRA-OPERATIVE COMPLICATIONS WERE SEEN IN THE TM GROUP. THERE WAS NO DIFFERENCE BETWEEN BOTH GROUPS IN RELATION TO EARLY POST-OPERATORY COMPLICATIONS: ALL OF THESE WERE DINDO GRADE II AND III AND WERE IN THE TM GROUP (2 WITH FEVER, 1 CYSTITIS) WHILE 4 IN THE OTHER GROUP (2 WITH FEVER, 1 ANEMIA, 1 CYSTITIS)." ON 26-JAN-2022, ISI CONTACTED THE AUTHOR(S) OF THIS ARTICLE AND ADDITIONAL INFORMATION WAS OBTAINED: THE REPORTER STATED THAT NO DA VINCI PRODUCT MALFUNCTIONS OCCURRED DURING THESE PROCEDURES. ALL THE INSTRUMENTS WERE INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTICED. THE FOUR PATIENTS WHO EXPERIENCED POST-OPERATIVE FEVERS AND TWO PATIENTS WHO EXPERIENCED POST-OPERATIVE CYSTITIS WERE TREATED WITH ANTIBIOTICS. IN REGARDS TO THE POST-OPERATIVE FEVERS AND POST-OPERATIVE CYSTITIS CASES, THE AUTHOR REPLIED THAT THE CAUSE WAS, "AVERAGE INCIDENCE OF POST-OPERATIVE COMPLICATION." THE PATIENT WHO EXPERIENCED POST-OPERATIVE ANEMIA WAS TREATED WITH AN ¿IRON-BASE CURE.¿ WHEN ASKED WHAT THE SURGEON BELIEVES THE CAUSE OF THIS COMPLICATIONS WAS THE REPORTER ANSWERED, ¿0.83% INCIDENCE OF POST-OPERATIVE COMPLICATION.¿ ONE PATIENT SUSTAINED A BLADDER INJURY INTRA-OPERATIVELY WHICH REQUIRED A CONVERSION TO OPEN SURGERY. THE REPORTER SAID THERE WAS NO MALFUNCTION OF A DA VINCI PRODUCT DURING THIS PROCEDURE. THE SURGEON WAS SEPARATING THE BLADDER AND UTERUS AND ENCOUNTERED ADHESION WHEN THE INJURY OCCURRED. THE REPORTER STATED THE CAUSE OF THE COMPLICATION WAS ¿ADHESIONS BETWEEN BLADDER AND UTERUS.¿ THIS PATIENT REPORTEDLY DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595541 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-04 N/A

    Patients

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