BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 23464140 · Received November 4, 2025

    Report

    Report Number
    1219930-2025-05080
    Event Type
    Death
    Date Received
    November 4, 2025
    Date of Event
    June 3, 2025
    Report Date
    November 4, 2025
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT#:UNKNOWN), UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#:UNKNOWN) ABUCHI OKARO, METABOLIC/BARIATRIC CLINICAL PRACTICE IN LAGOS, NIGERIA: A RETROSPECTIVE REVIEW OF THE CASES AND OUTCOMES OF OUR 10-YEAR EXPERIENCE, 2025, PANAFRICAN MEDICAL JOURNAL 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 UNDERGOING METABOLIC/BARIATRIC SURGERY FOR THE TREATMENT OF OBESITY BETWEEN JANUARY 2012 AND JUNE 2022. IT WAS NOTED THAT WHEN PERFORMING A LAPAROSCOPIC SLEEVE GASTRECTOMY, DISSECTION WAS PERFORMED WITH THE JAW SEALER OR A COMPETITOR PRODUCT, AND CUTTING AND STAPLING WERE PERFORMED WITH A LINEAR STAPLER OR A COMPETITOR PRODUCT. ADDITIONALLY, ONE OF THE PATIENTS THAT EXPERIENCED STAPLE LINE BLEEDING DIED OF MULTI ORGAN FAILURE SECONDARY TO HEMOLYTIC BLOOD TRANSFUSION REACTION. METABOLIC/BARIATRIC CLINICAL PRACTICE IN LAGOS, NIGERIA: A RETROSPECTIVE REVIEW OF THE CASES AND OUTCOMES OF OUR 10-YEAR EXPERIENCE, ABUCHI OKARO, 2025, PANAFRICAN MEDICAL JOURNAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212068 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN SURGICAL UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Death