BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 24905438 · Received April 16, 2026

    Report

    Report Number
    1219930-2026-02527
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    November 3, 2025
    Report Date
    April 30, 2026
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAFETY OF ROBOTIC HEPATIC PARENCHYMAL TRANSECTION USING SCISSOR HEPATECTOMY AND ALTERNATIVE TECHNIQUES: A COHORT STUDY ELISABETH MILLER, ALI KASSEM, NADIR NASIR, ERIK RASBACH, MORITZ SCHWAB, JAN HEIL, DOROTHÉE STURM, MARKO KORNMANN, NUH N. RAHBARI, EMRULLAH BIRGIN THE AUTHOR(S) 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 (IMF) 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 STUDY COMPARED THE OUTCOMES OF PATIENTS WHO UNDERWENT ROBOTIC HEPATECTOMY WITH PARENCHYMAL TRANSECTION VIA SCISSOR TECHNIQUE OR ALTERNATIVE TRANSECTION TECHNIQUES BETWEEN NOVEMBER 2020 AND DECEMBER 2024. IT WAS NOTED THAT PARENCHYMAL TRANSECTION WAS PERFORMED WITH COMPETITOR DEVICES AND MAJOR PEDICLES AND HEPATIC VEINS WERE DIVIDED USING A MANUAL STAPLER OR A COMPETITOR STAPLER. THERE WERE 207 PATIENTS INCLUDED IN THE STUDY AND COMPLICATIONS RELATED TO THE DEVICE INCLUDED HEMORRHAGE AND HEMATOMA REQUIRING BLOOD TRANSFUSION AND SURGICAL REVISION. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDED INTRA-ABDOMINAL FLUID COLLECTION AND BILE LEAKAGE. FIVE DEATHS OCCURRED WHICH WERE NOT DEVICE RELATED: TWO FROM POSTOPERATIVE CARDIAC FAILURE, TWO FROM POST HEPATECTOMY LIVER FAILURE IN CIRRHOTIC PATIENTS, AND ONE FROM CHOLANGIOCARCINOMA PROGRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613639 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN SURGICAL UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention