BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 22136720 · Received June 3, 2025

    Report

    Report Number
    2955842-2025-22644
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 7, 2025
    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
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: XI, X., YAN, G., GUO, B., JIN, G., GUO, C., & FENG, B. (2024). DIAPHRAGMATIC PHEOCHROMOCYTOMA: TWO CASE REPORTS AND A REVIEW OF THE LITERATURE. MEDICINE, 103(50), E40939. HTTPS://DOI.ORG/10.1097/MD.0000000000040939.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE DESCRIBED TWO CASES OF DIAPHRAGMATIC PHEOCHROMOCYTOMA AND THE USE OF THE DA VINCI SI ROBOTIC SYSTEM FOR TRANSABDOMINAL AND TRANSTHORACIC ROBOTIC SURGICAL RESECTION OF DIAPHRAGMATIC PHEOCHROMOCYTOMA. CASE A INVOLVED A PATIENT WHERE "A 3CM RUPTURE OF THE DIAPHRAGM WAS OBSERVED POSTOPERATIVELY. THE DIAPHRAGM WAS SUTURED AND THE PATIENT¿S LUNGS WERE INFLATED TO EXPEL GAS IN THE CHEST PRIOR TO CLOSURE OF THE CHEST CAVITY. AN ABDOMINAL DRAIN WAS INSERTED TO COMPLETE THE PROCEDURE, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE WARD." CASE B INVOLVED A PATIENT WHERE SUTURING WAS PERFORMED TO REPAIR INJURED PLEURA AND THE THORACIC CAVITY WAS ASSESSED FOR ANY AIR LEAK. A DRAINAGE TUBE WAS INSERTED THROUGH THE TROCAR CHANNEL AND LINKED TO A CLOSED THORACIC DRAINAGE DEVICE. THE ARTICLE CONCLUDED THAT "THE TRANSTHORACIC APPROACH TO DIAPHRAGMATIC PHEOCHROMOCYTOMA MAY PROVE TO BE MORE ADVANTAGEOUS THAN THE TRANSPERITONEAL APPROACH. ADDITIONALLY, PRECISE PREOPERATIVE LOCALIZATION OF THE TUMOR AND CAREFUL INTRAOPERATIVE MONITORING AND ASSESSMENT ARE IMPERATIVE TO ACHIEVE FAVORABLE OUTCOMES." THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR THE AUTHOR ALLEGED THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. INTUITIVE SURGICAL, INC. (ISI) 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
    876160 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES