BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 15131692 · Received July 29, 2022

    Report

    Report Number
    2955842-2022-13237
    Event Type
    Injury
    Date Received
    July 29, 2022
    Report Date
    June 30, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATIONS AS REFERENCED IN THE ARTICLE, WHICH INDICATED ¿TWO (2) PROCEDURES REQUIRED CLOSURE OF THE DEFECT WITH TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) PLATFORMS DUE TO TECHNICAL ISSUES¿ 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. VERIFICATION OF THE EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME BECAUSE THERE IS INSUFFICIENT EVENT DATE INFORMATION. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. THE SPECIFIC PROCEDURE/EVENT DATE IS UNKNOWN. THERE WAS NO IMAGE OR VIDEO CLIP RELATED TO A SPECIFIC EVENT SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE IT WAS REPORTED THAT ¿TWO (2) PROCEDURES REQUIRED CLOSURE OF THE DEFECT WITH TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) PLATFORMS DUE TO TECHNICAL ISSUES¿. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IN THIS CASE, THE CAUSE OF THIS INTRA-OPERATIVE COMPLICATION THAT ALLEGEDLY LEADING TO CONVERSION REMAINS UNKNOWN. NOTE: REFER TO THE REPORTS WITH PATIENT IDENTIFIERS (B)(6) FOR MDR SUBMISSION OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE ARTICLE THAT ARE NOT ASSOCIATED WITH THIS SPECIFIC REPORTED EVENT OF ¿TWO (2) PROCEDURES REQUIRED CLOSURE OF THE DEFECT WITH TEM PLATFORMS DUE TO TECHNICAL ISSUES¿. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. FIELD IS BLANK BECAUSE THE EVEN DATE IS UNKNOWN. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. 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, THROUGH AN ISI CLINICAL ARTICLE JOURNAL REVIEW, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A DISEASES OF THE COLON & RECTUM ARTICLE TITLED, ¿FIRST CLINICAL EXPERIENCE WITH SINGLE-PORT ROBOTIC TRANSANAL MINIMALLY INVASIVE SURGERY: PHASE II TRIAL OF THE INITIAL 26 CASES¿ (MARKS, J., KUNKEL, E., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: TWO (2) PROCEDURES REQUIRED CLOSURE OF THE DEFECT WITH TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) PLATFORMS DUE TO TECHNICAL ISSUES: ONE DUE TO MECHANICAL ISSUES WITH THE ROBOTIC PISTON AND THE OTHER DUE TO INSUFFLATION DIFFICULTIES. IN OUR INITIAL PROCEDURE, THE DEFECT WAS CLOSED BY HAND DUE TO THE DISTAL LOCATION OF THE LESION INTO THE ANAL CANAL IN A FASHION SIMILAR TO OUR EXPERIENCE WITH TEM AND TRANSANAL MINIMALLY INVASIVE SURGERY (TAMIS) SURGERY¿. FROM AVAILABLE INFORMATION, THE STUDY DATA WAS COLLECTED BETWEEN OCTOBER 2018 AND MARCH 2020 WITH A TOTAL OF 26 PATIENTS. THE ARTICLE CITES THE PURPOSE OF THE STUDY AS FOLLOWS: TO EVALUATE THE SAFETY AND FEASIBILITY OF THE INITIAL CLINICAL EXPERIENCE WITH SINGLE PORT ROBOT TRANSANAL MINIMALLY INVASIVE SURGERY. THE INDICATION FOR SURGERY WAS ADENOCARCINOMA. THIS REPORT COVERS THE CONVERSION DUE TO TECHNICAL ISSUES WITH THE ROBOT. THERE IS NO ALLEGATION OF A MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. AT THIS TIME, THE ROOT CAUSES OF THE REPORTED OPERATIVE COMPLICATIONS ARE UNKNOWN. ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR CONCERNING THE REFERENCED EVENTS FROM THE ARTICLE WITH NO SUCCESS. THE PATIENT'S DEMOGRAPHIC INFORMATION WAS NOT PROVIDED. NO PRODUCTS ARE AVAILABLE FOR ISI TO EVALUATE AS THERE WAS NO MALFUNCTION REPORTED. THIS COMPLAINT WILL BE PROCESSED BASED ON THE PROVIDED INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117218 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A

    Patients

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