BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SINGLE PORT SURGICAL SYSTEM

    MDR report key: 23454303 · Received November 3, 2025

    Report

    Report Number
    2955842-2025-43511
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    March 21, 2025
    Report Date
    December 2, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: LEE, J.H., GU, B. M., SONG, H. H., JANG, Y. J., & KIM, H. K. (2025). SINGLE-PORT ROBOT-ASSISTED MINIMALLY INVASIVE ESOPHAGECTOMY USING THE SINGLE-PORT ROBOTIC SYSTEM VIA THE SUBCOSTAL APPROACH: A SINGLE-CENTER RETROSPECTIVE STUDY. CANCERS, 17(7), 1052. HTTPS://DOI.ORG/10.3390/CANCERS17071052.

    Additional Manufacturer Narrative · 0

    SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE SURGICAL, INC. (ISI) WAS 10-OCT-2025.

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE, "SINGLE-PORT ROBOT-ASSISTED MINIMALLY INVASIVE ESOPHAGECTOMY USING THE SINGLE-PORT ROBOTIC SYSTEM VIA THE SUBCOSTAL APPROACH: A SINGLE-CENTER RETROSPECTIVE STUDY" WAS PERFORMED. THIS WAS A RETROSPECTIVE STUDY OF 53 PATIENTS WHO UNDERWENT MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) AT A SINGLE CENTER BETWEEN FEBRUARY 2017 AND DECEMBER 2024. PATIENTS UNDERWENT HYBRID LAPAROSCOPIC ROBOT-ASSISTED MINIMALLY INVASIVE ESOPHAGECTOMY (RAMIE), COMPRISING A ROBOTIC THORACIC PHASE AND LAPAROSCOPIC ABDOMINAL PHASE, WITH OR WITHOUT AN OPEN CERVICAL PHASE. THE ARTICLE NOTED THAT ONE 57-YEAR-OLD MALE PATIENT WHO UNDERWENT A DA VINCI SINGLE-PORT (SP) SURGERY REQUIRED REOPERATION OWING TO ANASTOMOTIC LEAKAGE FOLLOWING THE MCKEOWN PROCEDURE. THIS PATIENT ALSO HAD VOCAL CORD PALSY AND PNEUMONIA. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. STUDY LIMITATIONS INCLUDED: ALL THORACIC AND CERVICAL PROCEDURES WERE PERFORMED BY ONE THORACIC SURGEON, WHILE ALL ABDOMINAL PROCEDURES WERE PERFORMED BY ONE UPPER GASTROINTESTINAL SURGEON AT A SINGLE CENTER; THIS WAS A RETROSPECTIVE ANALYSIS WITH A LIMITED NUMBER OF PATIENTS INTRODUCING SELECTION BIAS; THERE WERE CONFOUNDING FACTORS, SUCH AS DIFFERENCES IN PATIENT COMORBIDITIES, TUMOR CHARACTERISTICS, AND SURGEON EXPERIENCE - WHICH MAY HAVE IMPACTED THE RESULTS; AS THE STANDARD APPROACH EVOLVED FROM VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) TO MULTI-PORT ROBOT-ASSISTED MINIMALLY INVASIVE ESOPHAGECTOMY (MRAMIE) AND THEN TO SINGLE PORT ROBOT-ASSISTED MINIMALLY INVASIVE ESOPHAGECTOMY (SRAMIE), A TIME-TREND BIAS WAS PRESENT, POTENTIALLY INFLUENCING OUTCOMES; AND FINALLY, THIS STUDY PRIMARILY FOCUSED ON SHORT-TERM PERIOPERATIVE OUTCOMES WITH NO DATA ON LONG-TERM ONCOLOGIC OUTCOMES. IT WAS NOTED THAT FURTHER PROSPECTIVE STUDIES WITH LONG-TERM FOLLOW-UP ARE REQUIRED. THE AUTHORS CONCLUDED THAT SRAMIE IS A FEASIBLE APPROACH OFFERING ADVANTAGES OVER VIDEO-ASSISTED THORACOSCOPIC ESOPHAGECTOMY IN RECOVERY AND POSTOPERATIVE PAIN. THE COMPARABLE PERIOPERATIVE OUTCOMES SUGGEST THAT SRAMIE MAY BE A VIABLE ALTERNATIVE TO CONVENTIONAL MIE, WARRANTING FURTHER LARGER-SCALE STUDIES. ISI HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067710 DA VINCI SINGLE PORT SURGICAL SYSTEM DA VINCI UNKNOWN NAY INTUITIVE SURGICAL, INC 380601 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.