BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 14571525 · Received June 2, 2022

    Report

    Report Number
    2955842-2022-11964
    Event Type
    Injury
    Date Received
    June 2, 2022
    Report Date
    May 3, 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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE PATIENTS' REPORTED COMPLICATIONS ASSOCIATED WITH RA HYSTERECTOMIES 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. A SYSTEM LOG REVIEW CANNOT BE PERFORMED DUE TO LACK OF SYSTEM AND PROCEDURE DETAILS. NO VIDEO OR IMAGES WERE PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿MINIMALLY INVASIVE HYSTERECTOMY FOR BENIGN INDICATIONS-SURGICAL VOLUME MATTERS: A RETROSPECTIVE COHORT STUDY COMPARING COMPLICATIONS OF ROBOTIC-ASSISTED AND CONVENTIONAL LAPAROSCOPIC HYSTERECTOMIES,¿ IT IS NOTED THAT A NUMBER OF PATIENTS WHO UNDERWENT DA VINCI-ASSISTED HYSTERECTOMY PROCEDURES EXPERIENCED OPERATIVE COMPLICATIONS. ONE PATIENT EXPERIENCED A UROLOGIC INJURY AND TWO PATIENTS WERE READMITTED FOR INFECTIONS. THE CAUSES OF THE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION IS NOT AVAILABLE. FIELD IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS ARE NOT APPLICABLE. FIELD IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿MINIMALLY INVASIVE HYSTERECTOMY FOR BENIGN INDICATIONS-SURGICAL VOLUME MATTERS: A RETROSPECTIVE COHORT STUDY COMPARING COMPLICATIONS OF ROBOTIC-ASSISTED AND CONVENTIONAL LAPAROSCOPIC HYSTERECTOMIES¿ (BARACY, M. G., JR., MARTINEZ, M., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, INJURIES INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE INCIDENCE OF PERIOPERATIVE COMPLICATIONS IN ROBOTIC-ASSISTED (RA) HYSTERECTOMIES PERFORMED BY HIGH-VOLUME ROBOTIC SURGEONS COMPARED TO CONVENTIONAL LAPAROSCOPIC HYSTERECTOMIES PERFORMED BY ALL GYNECOLOGIC SURGEONS. A RETROSPECTIVE COHORT STUDY WAS PERFORMED ON WOMEN AGE (B)(6) OR OLDER, WHO UNDERWENT A ROBOTIC-ASSISTED OR LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY FOR BENIGN INDICATIONS FROM (B)(6) 2016 THROUGH (B)(6) 2020 AT A LARGE COMMUNITY HOSPITAL. A TOTAL OF 332 PATIENTS UNDERWENT A HYSTERECTOMY FOR BENIGN INDICATIONS. HALF OF THE PATIENTS (N=166) RECEIVED CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY AND THE OTHER HALF RECEIVED A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY. THE FOLLOWING EVENTS WERE INJURIES REPORTED UNDER THE ROBOT ASSISTED HYSTERECTOMY STUDY GROUP: ONE UROLOGIC INJURY; TWO NONCATEGORIZED COMPLICATIONS IN THE RA HYSTERECTOMY GROUP THAT INCLUDED READMISSION FOR FEVER IN THE CONTEXT OF C. DIFFICILE INFECTION AND READMISSION FOR FEVER SECONDARY TO A COMPLICATED UTI; THREE OF "ANY COMPLICATION" WHICH WERE UNSPECIFIED. WITHIN THE ARTICLE, THE FOLLOWING WAS NOTED: "IT IS IMPORTANT TO NOTE THAT NONE OF THE COMPLICATIONS REPORTED IN THIS STUDY WERE ALLEGED TO BE FROM EQUIPMENT MALFUNCTION OR FAILURE." THE STUDY RESULT DEMONSTRATED A SIGNIFICANTLY LOWER INCIDENCE OF COMPLICATIONS IN ROBOTIC-ASSISTED HYSTERECTOMIES PERFORMED BY HIGH VOLUME SURGEONS COMPARED TO CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY. THERE WAS NO REPORT OR ALLEGATION FROM THE JOURNAL ARTICLE AUTHORS OF A SPECIFIC DEFICIENCY OF THE DAVINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. ISI HAS ATTEMPTED TO CONTACT THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION, BUT HAS NOT YET RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185912 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-06 N/A

    Patients

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