BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 24671625 · Received March 23, 2026

    Report

    Report Number
    1717344-2026-00434
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    December 27, 2025
    Report Date
    March 23, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#:UNKNOWN), UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#:UNKNOWN), UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#:UNKNOWN) AMIR ABDELLATEEF. "SURGICAL MANAGEMENT OF UNEXPECTED THYMIC ANATOMICAL VARIATIONS DURING THORACOSCOPIC THYMECTOMY", 2025, EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 2026, 68(1), EZAG027 ORIGINAL ARTICLE HTTPS://DOI.ORG/10.1093/EJCTS/EZAG027 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, AN OBSERVATIONAL STUDY COMPARED THE OUTCOMES OF PATIENTS WITH THYMIC ANATOMICAL VARIATIONS WHO UNDERWENT VIDEO-ASSISTED THORACOSCOPIC SURGERY THYMECTOMY FOR THE TREATMENT OF MYASTHENIA GRAVIS BETWEEN SEPTEMBER 2016 AND SEPTEMBER 2024. IT WAS NOTED THAT DISSECTION AND SEALING WAS ACCOMPLISHED WITH A LIGASURE DEVICE AND A COMPETITOR PRODUCT SIMULTANEOUSLY. ADDITIONALLY, AFTER DISSECTION, PROXIMAL THYMIC TRIBUTARIES TOWARDS THE RETRO-LEFT BRACHIOCEPHALIC VEIN WERE CLIPPED AND FOLLOWED BY DISTAL SEALING WITH AN ENERGY SEALING DEVICE. THERE WERE 255 PATIENTS INCLUDED IN THE STUDY AND INTRAOPERATIVE COMPLICATIONS INCLUDED BLEEDING, AND DIAPHRAGMATIC INJURY. BLEEDING ALSO NOTED ON POSTOPERATIVE COMPLICATIONS. TITLE: SURGICAL MANAGEMENT OF UNEXPECTED THYMIC ANATOMICAL VARIATIONS DURING THORACOSCOPIC THYMECTOMY AUTHOR: AMIR ABDELLATEEF DATE OF PUBLICATION: DECEMBER 27, 2025

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732535 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female