BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI

    MDR report key: 14783062 · Received June 22, 2022

    Report

    Report Number
    2955842-2022-12298
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    May 13, 2020
    Report Date
    November 26, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME BECAUSE OF INSUFFICIENT PRODUCT INFORMATION. THE EVENT DATES AND DA VINCI SYSTEM INFORMATION ARE UNKNOWN. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE¿ IT IS NOTED THAT 5 DA VINCI-ASSISTED LOBECTOMY PROCEDURES WERE CONVERTED TO THORACOTOMY PROCEDURES FOR THE FOLLOWING: 2 INJURIES OF THE PULMONARY ARTERY, 1 INJURY OF THE AORTA, 1 INJURY OF THE INTERLOBAR VEIN, AND 1 LYMPH NODE INFILTRATION TO THE PULMONARY ARTERY. THE CAUSES OF THE INTRA-OPERATIVE COMPLICATIONS ARE UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.

    Description of Event or Problem · 0

    ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE¿ (SATO, T., ET. AL. 2020). IN THIS STUDY, CLINICAL DATA OF 65 PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED THORACOSCOPIC SURGERY (RATS) LOBECTOMY PROCEDURES FROM DECEMBER 2011 TO APRIL 2019 AT A SINGLE INSTITUTION WERE RETROSPECTIVELY INVESTIGATED. THE DA VINCI SI SURGICAL SYSTEM HAD BEEN USED AT THE SITE FROM 2011 TO 2017 AND WAS REPLACED BY THE DA VINCI XI SURGICAL SYSTEM AFTERWARDS. WITHIN THE ARTICLE, THERE WERE 5 CASES WHERE THE DA VINCI-ASSISTED LOBECTOMY PROCEDURES WERE CONVERTED TO OPEN THORACOTOMY PROCEDURES. DETAILS OF THE CONVERSIONS ARE AS FOLLOWS: "IN CASE 1, THE CAUSE OF CONVERSION WAS UNCONTROLLABLE BLEEDING FROM AN INJURY TO THE LINGUAL SEGMENTAL PULMONARY ARTERY DURING STAPLING OF THE INCOMPLETE INTERLOBAR FISSURE. IN CASE 2, THE AORTA WAS PARTIALLY STAPLED UPON DIVIDING THE INTERLOBAR FISSURE BETWEEN THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE AND THE APICAL SEGMENT OF THE LEFT LOWER LBOE, WHICH WAS REPAIRED BY END-TO-END ANASTOMOSIS UNDER BYPASSING THE EXTRACORPOREAL MEMBRANOUS OXYGENATION IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED. IN CASE 3, WHEN DISSECTING THE ARTERIAL BRANCH TO APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE, THE ROOT OF THE BRANCH WAS INJURED AND THE SURGERY WAS CONVERTED TO OPEN THORACOTOMY. IN CASE 4, THE INJURY OF HE BRIDGING VEIN BETWEEN THE RIGHT UPPER LOBE AND LOWER LOBE RESULTED IN THE UNEXPECTED CONVERSION OF THORACOTOMY. IN CASE 5, THE OPERATOR CHOSE CONVERSION BECAUSE OF THE INFILTRATED LYMPH NODE IN THE ROOT OF THE PULMONARY ARTERY BRANCH OF THE LINGUAL SEGMENT" THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264702 DAVINCI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

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