BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 23463593 · Received November 4, 2025

    Report

    Report Number
    2647580-2025-03278
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    April 21, 2025
    Report Date
    November 4, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KAMAL S. YADAV, NIKHITHA SHETTY, FYSAL VALAPPIL, AKASH SELVATHANGAM, SUCHET CHAUDHARY, ANKUR GUPTA, PRASHANT BHANGUI, AND ARVINDER S. SOIN. "COMPLEX DONOR ANATOMY DOES NOT INFLUENCE EARLY DONOR OR RECIPIENT OUTCOMES AFTER ROBOTIC DONOR HEPATECTOMY AT A HIGH-VOLUME CENTER." AMERICAN JOURNAL OF TRANSPLANTATION, VOLUME 25, 1987¿1995, 2025. HTTPS://DOI.ORG/10.1016/J.AJT.2025.04.017 D10 CONCOMITANT PRODUCT: UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU, (LOT NUMBER: UNKNOWN). 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 CONDUCTED AT A HIGH-VOLUME LIVER TRANSPLANT CENTER COMPARED DONOR AND RECIPIENT OUTCOMES OF ROBOTIC DONOR HEPATECTOMY USING STANDARD AND COMPLEX GRAFTS BETWEEN APRIL 2022 AND MAY 2024. AMONG THE 227 CASES OF ROBOTIC DONOR HEPATECTOMY ANALYZED, INTRAOPERATIVE BLEEDING OCCURRED IN SOME CASES, INCLUDING ONE INCIDENT WHERE PARTIAL SLIPPAGE OF A VASCULAR CLIP LED TO ARTERIAL BLEEDING REQUIRING RE-EXPLORATION. IN SIX DONORS, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO BLEEDING OR DIFFICULT INTRA-ABDOMINAL CONDITIONS. DONORS WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION WHEN INDICATED, AND ALL PATIENTS RECOVERED AFTER APPROPRIATE SURGICAL AND SUPPORTIVE MANAGEMENT. THE STUDY REPORTED NO DONOR DEATHS AND SIMILAR HOSPITAL STAY DURATIONS FOR BOTH STANDARD AND COMPLEX GRAFT GROUPS, CONFIRMING THAT ROBOTIC DONOR HEPATECTOMY USING THE MANUAL STAPLER REMAINED SAFE AND EFFECTIVE EVEN WHEN BLEEDING COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720664 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Hospitalization| R SEE H11.