BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 23308946 · Received October 16, 2025

    Report

    Report Number
    1219930-2025-04728
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    June 26, 2025
    Report Date
    October 16, 2025
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MATTEO DE PASTENA, GABRIELLA LIONETTO, SALVATORE PAIELLA, MARTINA MARUCCIO, FEDERICO FAUSTINI, ELISA VENTURINI, ANTONIO PEA, FABIO C ASCIANI, GIUSEPPE MALLEO, AND ALESSANDRO ESPOSITO. "SURGICAL AND ONCOLOGICAL OUTCOMES OF MINIMALLY INVASIVE LEFT PANCREATECTOMY FOR PANCREATIC CANCER: ROBOTIC VS. LAPAROSCOPIC APPROACH." CURR. ONCOL. 2025, 32, 376. 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 SOURCE OF STUDY PERFORMED BETWEEN JANUARY 2013 AND DECEMBER 2023, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC VERSUS ROBOTIC LEFT PANCREATECTOMY FOR THE TREATMENT O PANCREATIC CANCER. A TOTAL OF 54 PATIENTS WERE INCLUDED AND UNDERWENT MINIMALLY INVASIVE LEFT PANCREATECTOMY (MILP) FOR PANCREATIC DUCTAL ADENOCARCINOMA (PDAC) DURING THE STUDY PERIOD. IT WAS NOTED THAT THE PANCREATIC STUMP WAS MANAGED WITH A 60-MILLIMETER (MM) REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY OR A COMPETITOR ULTRASONIC DISSECTOR. COMPLICATIONS INCLUDED CONVERSION TO OPEN, INTRA OPERATIVE BLOOD TRANSFUSION, CLINICALLY SIGNIFICANT POST-OPERATIVE PANCREATIC FISTULA, POST-PANCREATECTOMY HEMORRHAGE AND ORGAN/SPACE SURGICAL SITE INFECTION. REOPERATION AND/OR READMISSION WAS REQUIRED IN 2 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2737159 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN SURGICAL UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H