BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 14786076 · Received June 23, 2022

    Report

    Report Number
    2955842-2022-12326
    Event Type
    Injury
    Date Received
    June 23, 2022
    Report Date
    November 26, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    N/A
    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 COMPLICATION 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. AN INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME BECAUSE OF INSUFFICIENT PRODUCT INFORMATION. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW AND NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE, WHEN DISSECTING THE ARTERIAL BRANCH TO THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE, THE ROOT OF THE BRANCH WAS INJURED AND THE SURGERY WAS CONVERTED TO OPEN THORACOTOMY. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY). THE FOLLOWING DETAILS WERE UNKNOWN: THE SPECIFIC INSTRUMENT(S) INVOLVED WITH THE EVENT. IT WAS UNKNOWN IF THERE WAS EXCESSIVE BLOOD LOSS, WHAT THE ESTIMATED BLOOD LOSS WAS, AND/OR IF A BLOOD TRANSFUSION WAS REQUIRED. IT WAS UNKNOWN WHAT SPECIFIC MEDICAL INTERVENTION WAS PERFORMED AFTER THE CONVERSION TO OPEN SURGERY. THE PATIENT¿S CURRENT STATUS WAS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EVENT DATE IS UNKNOWN. 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.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #3 INVOLVED A 69 YEAR OLD MALE PATIENT WITH STAGE 1B CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY). ¿IN CASE 3, WHEN DISSECTING THE ARTERIAL BRANCH TO THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE, THE ROOT OF THE BRANCH WAS INJURED AND THE SURGERY WAS CONVERTED TO OPEN THORACOTOMY.¿ 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
    290372 DA VINCI DA VINCI XI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES