BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 24234229 · Received February 2, 2026

    Report

    Report Number
    1717344-2026-00146
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    October 8, 2025
    Report Date
    February 2, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#UNKNOWN) LAPAROSCOPIC ADRENALECTOMY: EXPERIENCE IN A TERTIARY CARE HOSPITAL IN EASTERN INDIA. DR. PARTHA PROTIM MONDAL, DR. SHIVA MANOHAR DUTTA, DR. PANKAJ MUDGIL, DR. VED PRAKASH PATEL, AND DR. BABAR ALI. J MED. PHARM. RES., 6 (5): 1798-1804, 2025. AVAILABLE ONLINE: 24-10-2025 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 ANALYZED OUTCOMES IN PATIENTS WHO UNDERWENT LATERAL TRANSPERITONEAL LAPAROSCOPIC ADRENALECTOMY BETWEEN DECEMBER 2022 AND OCTOBER 2024. LIGASURE OR ANOTHER DEVICE WERE USED TO RELEASE ALL SPLENIC ATTACHMENTS AND TO DIVIDE THE ADRENAL VESSELS. THERE WERE 24 PATIENTS IN THE STUDY AND TWO PATIENTS REQUIRED OPEN CONVERSION DUE TO UNCONTROLLED INTRAOPERATIVE BLEEDING FROM RIGHT ADRENAL VEIN WHICH WAS TORN AT ITS JUNCTION FROM INFERIOR VENA CAVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293102 UNKNOWN LIGASURE INSTRUMENT Electrosurgical, cutting & coagulation & accessories GEI COVIDIEN UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention PLEASE SEE NOTE ON H11.