BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 9209540 · Received October 18, 2019

    Report

    Report Number
    1219930-2019-05905
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    February 8, 2018
    Report Date
    October 18, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: COMPARATIVE STUDY OF THE INITIAL EXPERIENCE IN PERFORMING ROBOTIC AND LAPAROSCOPIC RIGHT HEPATECTOMY WITH TECHNICAL DESCRIPTION OF THE ROBOTIC TECHNIQUE SOURCE DIGESTIVE SURGERY, VOLUME 36, 2019 (241¿250) DATE OF PUBLICATION: 14 MARCH 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF A STUDY PERFORMED ABOUT THE INITIAL EXPERIENCE IN PERFORMING ROBOTIC AND LAPAROSCOPIC RIGHT HE PATECTOMY WITH TECHNICAL DESCRIPTION OF THE ROBOTIC TECHNIQUE, WHICH AIMS TO EVALUATE THE FEASIBILITY OF COMPLEX ROBOTIC LIVER OPERATIONS COMPARED TO LAPAROSCOPIC LIVER SURGERIES, THERE WERE HIGHER RATES OF COMPLICATIONS EXPERIENCED IN THE LAPAROSCOPIC ARM. THE OP ERATIVE DATA AND INITIAL OUTCOMES OF THE 20 LAPAROSCOPIC PATIENTS INVOLVED IN THE STUDY WITH THE MEAN AGE OF 65.9, SHOW THE FOLLOWING COMPLICATIONS: 5 CASES OF CONVERSION TO OPEN SURGERY. IN 2 CASES, THE PROCEDURE WAS CONVERTED INTO OPEN DUE TO INTRAOPERATIVE BLEEDING, AND IN 3 ¿ VASCULAR INVASION THAT REQUIRED THE VESSEL RESECTION WITH FOLLOWING RECONSTRUCTION. ONE REOPERATION WAS ALSO PERFORMED IN A PATIENT DUE TO POSTOPERATIVE HEMORRHAGE. THERE WAS ALSO BILE LEAKAGE IN 2 CASES AND TRANSITORY LIVER FAILURE IN 1. THE MORBIDITY RATE WAS 15%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002287 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention