BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 23235507 · Received October 7, 2025

    Report

    Report Number
    1717344-2025-01265
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 7, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXTENDED USE OF CENTRAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION IN LUNG TRANSPLANTATION FOR PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION / MITSUAKI KAWASHIMA, NAOHIRO IJIRI, CHIHIRO KONOEDA, GOUJI TOYOKAWA, KEITA NAKAO, YUE CONG, HARUAKI HINO, HIDEO KUROSAWA, KOICHI KASHIWA, MICHIKO USHIO, GAKU KAWAMURA, MASAHIKO ANDO, SHOGO SHIMADA, MINORU ONO, MASAAKI SATO / EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 2025, 67(8), EZAF256 ORIGINAL ARTICLE / HTTPS://DOI.ORG/10.1093/EJCTS/EZAF256 ADVANCE ACCESS PUBLICATION 4 AU GUST 2025 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, A RETROSPECTIVE STUDY REPORTED THE OUTCOMES OF PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION WHO UNDERWENT BILATERAL LUNG TRANSPLANTATION USING POSTOPERATIVE CENTRAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION COMBINED WITH DELAYED CHEST CLOSURE BETWEEN JANUARY 2021 AND DECEMBER 2024. IT WAS NOTED THAT HEMOSTASIS WAS ACHIEVED WITH LIGATION, CLIPPING, LIGASURE MARYLAND, OR A COMBINATION OF THESE METHODS. OOZING/BLEEDING AND REOPERATION WERE IDENTIFIED IN THESE AREAS. THERE WERE 20 PATIENTS INCLUDED IN THE STUDY AND HEMOTHORAX WAS TREATED WITH EVACUATION IN 9 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652101 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention