BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SURGICAL SYSTEM

    MDR report key: 12822126 · Received November 16, 2021

    Report

    Report Number
    2955842-2021-11522
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    June 30, 2021
    Report Date
    October 18, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A SPECIFIC DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION, OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. SITE HISTORY COMPLAINT REVIEW WAS UNABLE TO BE CONDUCTED AT THIS TIME DUE TO LACK OF SYSTEM AND INSTRUMENT DETAIL AND LACK OF SPECIFIC EVENT/PROCEDURE DETAIL. SYSTEM OR INSTRUMENT LOG REVIEW COULD NOT BE PERFORMED DUE TO LACK OF SITE, SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: THE CANCERS JOURNAL ARTICLE TITLED, ¿COMPARISON OF SURGICAL OUTCOMES BETWEEN ROBOTIC TRANSAXILLARY AND CONVENTIONAL OPEN THYROIDECTOMY IN PEDIATRIC THYROID CANCER¿ CITED PERIOPERATIVE AND POSTOPERATIVE COMPLICATIONS DURING A RETROSPECTIVE REVIEW FROM FEBRUARY 2008 TO DECEMBER 2019, OF PROCEDURES COMPLETED ON A DA VINCI SI, XI, OR SP SURGICAL ROBOTIC SYSTEM. AT THIS TIME, THE ROOT CAUSES OF THE ALLEGED COMPLICATIONS ARE UNKNOWN. IT IS ALSO UNKNOWN WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE COMPLICATIONS. THERE IS NO ALLEGATION WITHIN THE JOURNAL ARTICLE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    ON 18-OCT-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A CANCERS JOURNAL ARTICLE TITLED, ¿COMPARISON OF SURGICAL OUTCOMES BETWEEN ROBOTIC TRANSAXILLARY AND CONVENTIONAL OPEN THYROIDECTOMY IN PEDIATRIC THYROID CANCER¿ (LEE, I. A., KIM, K., ET AL., 2021). IT WAS CITED THAT THIS WAS A RETROSPECTIVE REVIEW FROM FEBRUARY 2008 TO DECEMBER 2019, OF PROCEDURES COMPLETED ON A DA VINCI SI, XI, OR SP SURGICAL ROBOTIC SYSTEM, WHICH INCLUDED 161 PEDIATRIC (19 YEARS OR YOUNGER) PATIENTS WHO UNDERWENT THYROIDECTOMY PROCEDURES FOR THYROID CANCER FROM FEBRUARY 2008 AND DECEMBER 2019 - [ROBOTIC TRANSAXILLARY (RT); 99 PATIENTS] OR [CONVENTIONAL OPEN (COT); 60 PATIENTS]. WITHIN THE JOURNAL ARTICLE, PERIOPERATIVE AND POSTOPERATIVE COMPLICATIONS WERE CITED. THE PERIOPERATIVE COMPLICATIONS WERE DESCRIBED AS FOLLOWS: "HEMATOMA, SEROMA, WOUND INFECTION, HYPOCALCEMIA (TRANSIENT OR PERMANENT), CHYLE LEAKAGE, VOCAL CORD PALSY (TRANSIENT HOARSENESS OR PERMANENT RECURRENT LARYNGEAL NERVE PALSY), OCULO-SYMPATHETIC PARESIS (HORNER¿S SYNDROME), TRACHEA INJURY, ESOPHAGEAL INJURY, AND BRACHIAL PLEXUS NEUROPRAXIA." THE ARTICLE CITED THAT ¿ALL THE PATIENTS WERE FOLLOWED UP ON IN THE SAME MANNER, INCLUDING CLINICAL EXAMINATIONS WITHIN 1 WEEK OF DISCHARGE." THE ARTICLE ALSO CITED POSTOPERATIVE COMPLICATIONS, WHICH OCCURRED IN 21 (21.2%) OF THE ROBOTIC CASES VERSUS 25 (40.3%) IN THE CONVENTIONAL OPEN GROUP, WERE DESCRIBED AS FOLLOWS: TRANSIENT OR PERMANENT HYPOCALCEMIA, CHYLE LEAKAGE, WOUND INFECTION, TRANSIENT OR PERMANENT RLN INJURY, AND OCULO-SYMPATHETIC PARESIS (HORNER¿S SYNDROME). ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION. IT WAS REPORTED FROM AN UNIDENTIFIED INDIVIDUAL AT THE SITE THAT THE AUTHOR WAS NOT THE SURGEON WHO PERFORMED THE PROCEDURES WITHIN THE JOURNAL. THE AUTHOR WAS AN ASSISTANT SURGICAL STAFF, AND SHE WAS NOT AVAILABLE TO ANSWER THE QUESTIONS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717013 DAVINCI SURGICAL SYSTEM DAVINCI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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