BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 24674228 · Received March 24, 2026

    Report

    Report Number
    2955842-2026-17299
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    May 5, 2025
    Report Date
    March 3, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. CITATION: TAWALBEH, R., ET AL. (2025). NEXT-DAY DISCHARGE IS FEASIBLE IN ROBOTIC-ASSISTED THORACIC SURGERY ANATOMICAL LUNG RESECTIONS IRRESPECTIVE OF PATIENT CHARACTERISTICS. JOURNAL OF CLINICAL MEDICINE, 14, 3198. HTTPS://DOI.ORG/10.3390/JCM14093198. SECTION A2: PATIENT INFORMATION AGE: REFLECTS THE STUDY MEAN AGE OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION A3A- PATIENT GENDER REPRESENTS THE MAJORITY OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION D: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED. SECTION E - THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE FIRST AUTHOR'S ASSOCIATED HOSPITAL. WHILE THE EXACT SITE IS UNKNOWN, THIS DESIGNATION IS CONSIDERED AN APPROPRIATE SUBSTITUTION. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY ISI, RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT.

    Description of Event or Problem · 0

    A REVIEW OF AN ARTICLE THAT AIMS TO COMPARE NEXT-DAY DISCHARGE ROBOTIC-ASSISTED THORACIC SURGERY (RATS) ANATOMICAL LUNG RESECTION PATIENTS MATCHED WITH PATIENTS WHO STAYED LONGER WAS PERFORMED. THE STUDY IS A RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT RATS ANATOMICAL LUNG RESECTION BY A SINGLE SURGEON WAS CONDUCTED. THE STUDY ANALYZED 202 PATIENTS UNDERGOING RATS BETWEEN (B)(6) 2021 AND (B)(6) 2024. A TOTAL OF 24 PATIENTS EXPERIENCED COMPLICATIONS, INCLUDING PNEUMONIA, CHEST INFECTIONS, ATELECTASIS, EMPYEMA, AND CONSOLIDATION AND WERE TREATED WITH INTRAVENOUS ANTIBIOTICS AND, WHEN NECESSARY, CHEST DRAIN REINSERTION. AIR LEAK COMPLICATIONS, INCLUDING PROLONGED AIR LEAKS, WERE MANAGED WITH CONTINUED CHEST DRAINAGE AND DISCHARGE WITH FLUTTER BAGS. PLEURAL COLLECTIONS REQUIRED INTERVENTIONAL DRAINAGE. A BRONCHOPLEURAL FISTULA WAS REPORTED AND REQUIRED CHEST DRAIN REINSERTION. CARDIAC COMPLICATIONS, SUCH AS ARRHYTHMIA, AND RENAL COMPLICATIONS, SUCH AS ACUTE KIDNEY INJURY, WERE NOTED, THOUGH TREATMENTS WERE NOT SPECIFIED. A NEUROLOGICAL COMPLICATION (STROKE) WAS ALSO REPORTED WITHOUT TREATMENT DETAILS. ADDITIONALLY, THE ARTICLE DOCUMENTED HOSPITAL READMISSIONS FOR CHEST INFECTIONS (INCLUDING CASES REQUIRING CHEST DRAIN REINSERTION), STROKE, BRONCHOPLEURAL FISTULA, AND PLEURAL COLLECTIONS REQUIRING DRAINAGE. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE NO MALFUNCTIONS WITH THE DA VINCI SYSTEM OR RELATED COMPONENTS, "THE COMPLICATIONS ARE ONLY RELATED TO THE LUNG RESECTIONS AND NOT TO ANY ISI PRODUCTS; NOT RELATED TO ROBOTIC OPERATING WITH DAVINCI - WE WOULD RECORD SUCH COMPLICATIONS IF WE WERE DOING THE PROCEDURES VIDEO ASSISTED THORACIC SURGERY (VATS) OR OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238248 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.