BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSCOUNTRY

    MDR report key: 22919988 · Received August 28, 2025

    Report

    Report Number
    3004962788-2025-00096
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 28, 2025
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    EOQ
    UDI-DI
    10884521809536
    PMA / PMN Number
    K142934
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALISS T.C. CHANG, JOYCE W.Y. CHAN, IVAN C.H. SIU, RAINBOW W.H. LAU, CHEUK MAN CHU, TONY S.K. MOK, AND CALVIN S.H. NG. "HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION." INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY 2025, 40(7), IVAF152. HTTPS://DOI.ORG/10.1093/ICVTS/IVAF152 ADVANCE ACCESS PUBLICATION 27 JUNE 2025 D10 CONCOMITANT PRODUCTS: ILS-1000-CS, ILS-1000-CS ILLUMISITE CONSOLE, (SERIAL NUMBER: UNKNOWN) AAS00161-20, AAS00161-20 US SUPERD NAVIGATION SYSTEM, (SERIAL NUMBER: UNKNOWN) UNK NEEDLE, UNKNOWN BIOPSY NEEDLE, (LOT NUMBER: UNKNOWN) UNK EWC, UNKNOWN EXTENDED WORKING CHANNEL, (LOT NUMBER: UNKNOWN) UNK EMPRINT ANT, UNKNOWN EMPRINT ANTENNA, (LOT NUMBER: UNKNOWN) UNK EMPRINT ANT, UNKNOWN EMPRINT ANTENNA, (LOT NUMBER: UNKNOWN) ILS-1000-CS, ILS-1000-CS ILLUMISITE CONSOLE, (SERIAL NUMBER: UNKNOWN) SDATSW01, SDATSW01 ACCESS TOOL STRAIGHT WIRE, (LOT NUMBER: UNKNOWN) AAS00161-20, AAS00161-20 US SUPERD NAVIGATION SYSTEM, (SERIAL NUMBER: UNKNOWN) UNK NEEDLE, UNKNOWN BIOPSY NEEDLE, (LOT NUMBER: UNKNOWN) UNK EWC, UNKNOWN EXTENDED WORKING CHANNEL, (LOT NUMBER: UNKNOWN) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MARCH 2019 TO FEBRUARY 2024, A RETROSPECTIVE STUDY ANALYZED THE HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION WITH CONCOMITANT VIDEO-ASSISTED THORACOSCOPIC LUNG RESECTION. A TOTAL OF 92 PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE 103 PROCEDURES PERFORMED AND 162 LUNG NODULES TREATED 142 LUNG NODULES WERE ABLATED AND 20 LUNG NODULES WERE RESECTED. 6 PATIENTS HAD COMPLICATIONS INCLUDING (1) PERSISTED FEVER, (2) AIRWAY BLEEDING, (2) PNEUMOTHORAX AND (1) BRONCHOPLEURAL FISTULA. ORAL ANTIBIOTICS WERE GIVEN, CHEST TUBE DRAINAGE WAS DONE AND ENDOBRONCHIAL VALVE PLACEMENT ON. RE-ADMISSION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131317 CROSSCOUNTRY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ COVIDIEN LP - SUPERDIMENSION INC SDATSW01 10884521809536

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention SEE H11