BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 22382910 · Received July 2, 2025

    Report

    Report Number
    2955842-2025-27527
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    January 25, 2025
    Report Date
    June 7, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 ION SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY ION PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY ION PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATION: NADIG, T. R., DAVE, J. R., ADUSUMILLI, P. S., BOTT, M. J., CHAWLA, M., GRAY, K. D., HUSTA, B. C., LEE, R. P., OBERG, C. L., PARK, B. J., ROCCO, G., BAINE, M. K., & KALCHIEM-DEKEL, O. (2025). ROBOTIC-ASSISTED BRONCHOSCOPY FOR THE DIAGNOSIS OF BENIGN PULMONARY TUMORS. RESPIRATORY MEDICINE, 107963. HTTPS://DOI.ORG/10.1016/J.RMED.2025.107963.

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE TITLED, "ROBOTIC-ASSISTED BRONCHOSCOPY FOR THE DIAGNOSIS OF BENIGN PULMONARY TUMORS," WAS PERFORMED. THIS ARTICLE WAS A RETROSPECTIVE ANALYSIS OF A PROSPECTIVE DATABASE OF ALL ROBOTIC-ASSISTED BRONCHOSCOPY (RAB) CASES PERFORMED IN A SINGLE HIGH-VOLUME CANCER CENTER. THE RAB CASES WERE PERFORMED USING THE ION SHAPE SENSING RAB (SSRAB) PLATFORM. THERE WERE 1931 SSRAB PROCEDURES PERFORMED DURING THE STUDY PERIOD. TWENTY-FOUR INDIVIDUAL PATIENT PROCEDURES TARGETING 25 PARENCHYMAL LUNG LESIONS MET PATHOLOGICAL INCLUSION CRITERIA FOR THE STUDY. THE MEDIAN AGE WAS 63 YEARS AND 54% WERE FEMALE. THERE WAS ONE PNEUMOTHORAX IN ALL OF THE SSRAB CASES THAT REQUIRED TUBE THORACOSTOMY. THERE WERE NO INSTANCES OF GRADE >/=3 BLEEDING. THE ARTICLE STATES THAT RAB IS EMERGING AS A VALUABLE TOOL IN THE INVESTIGATION OF PARENCHYMAL LUNG LESIONS. THE AUTHORS CONCLUDED THAT SSRAB DEMONSTRATES AN ACCEPTABLE DIAGNOSTIC YIELD FOR BENIGN PULMONARY TUMORS. WHEN THE PRE-OPERATIVE PROBABILITY OF A BENIGN TUMOR IS SUFFICIENTLY HIGH, PROVIDERS SHOULD CONSIDER USING TBFB OR TBCB TO OPTIMIZE DIAGNOSTIC TISSUE ACQUISITION AND ANTICIPATE A NEGATIVE INTRA-OPERATIVE ROSE ADEQUACY. ADDITIONALLY, THE ARTICLE NOTES THAT FUTURE STUDIES ARE NEEDED TO REFINE THE DIAGNOSTIC APPROACH TO THIS SUBTYPE OF LUNG LESIONS AND AGGREGATE MULTI-INSTITUTIONAL EXPERIENCE. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ION ENDOLUMINAL SYSTEM