BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 23788846 · Received December 12, 2025

    Report

    Report Number
    1717344-2025-01592
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    July 20, 2025
    Report Date
    December 12, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#: UNKNOWN) TRANSANAL ENDOSCOPIC MICROSURGERY WITH THE FLUORESCENCE LYMPHANGIOGRAPHY / KSENIIA VOROTYNTSEVA, VLADYMYR GRUBNIK AND VIKTOR GRUBNYK / SURGICAL ENDOSCOPY (2025) 39:6478¿6485 / HTTPS://DOI.ORG/10.1007/S00464-025-12037-0 / PUBLISHED ONLINE: 11 AUGUST 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 PROSPECTIVE COHORT STUDY EVALUATED THE UTILIZATION OF INDOCYANINE GREEN (ICG) FLUORESCENCE LYMPHANGIOGRAPHY INTO TRANSANAL ENDOSCOPIC MICROSCOPIC SURGERY FOR SENTINEL LYMPH NODE DETECTION BETWEEN 2009-2024. IT WAS NOTED THAT THE RECTAL LESION WAS EXCISED WITH A FULL-THICKNESS RESECTION OF THE RECTAL WALL AND A LIGASURE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE 95 PATIENTS INCLUDED IN THE STUDY. 4 PATIENTS EXPERIENCED SIGNIFICANT RECTAL BLEEDING POSTOP, WHICH WERE TREATED WITH A REPEAT ENDOSCOPIC INTERVENTION AND COAGULATION SUCCESSFULLY MANAGED WITH THE LIGASURE DEVICE. ADDITIONALLY, 3 PATIENTS WITH TUMORS LOCATED IN THE HIGH RECTUM, FULL THICKNESS EXCISION RESULTED IN AN OPENING INTO THE PERITONEAL CAVITY. THESE PATIENTS WERE TREATED WITH A LAPAROSCOPY AND SUTURING OF THE RECTAL WALL DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2710497 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention PLEASE SEE NOTE ON H11.