BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 25174183 · Received May 14, 2026

    Report

    Report Number
    1717344-2026-00670
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    December 16, 2025
    Report Date
    May 14, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNEGIATRI, UNKNOWN EGIA TRI STAPLE (LOT#UNKNOWN) COMPARISON OF EARLY RESULTS OF AESTHETIC FOCUSED BIKINI-LINE SLEEVE GASTRECTOMY AND STANDARD LAPAROSCOPIC SLEEVE GASTRECTOMY, TUNA BILECIK, OBESITY SURGERY (2026) 36:628-638, PUBLISHED ONLINE: JANUARY 2, 2026 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 COMPARED THE OUTCOMES OF PATIENTS WHO UNDERWENT BIKINI LINE SLEEVE GASTRECTOMY VERSUS STANDARD LAPAROSCOPIC SLEEVE GASTRECTOMY FOR THE TREATMENT OF OBESITY BETWEEN JANUARY 2023 TO DECEMBER 2023. IT WAS NOTED THAT A 44 MM LIGASURE DEVICE WAS THE BIPOLAR ENERGY SOURCE IN ALL SURGERIES. THERE WERE 364 PATIENTS INCLUDED IN THE STUDY AND BLEEDING OCCURRED IN EIGHT PATIENTS. INTERVENTIONS AND PATIENT OUTCOMES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611548 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown Other PLEASE SEE NOTE ON H11.