BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 14681581 · Received June 13, 2022

    Report

    Report Number
    1219930-2022-02212
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    November 6, 2020
    Report Date
    June 13, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE: TITLE: REINFORCED VERSUS STANDARD STAPLER TRANSECTION ON POSTOPERATIVE PANCREATIC FISTULA IN DISTAL PANCREATECTOMY: MULTICENTRE RANDOMIZED CLINICAL TRIAL SOURCE: BJS, 2021, 108, 265¿270 DOI: 10.1093/BJS/ZNAA113 ADVANCE ACCESS PUBLICATION DATE: 20 JANUARY 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT DISTAL PANCREATECTOMY TO EVALUATE THE EFFECT OF STAPLE REINFORCEMENT BETWEEN MAY 2014 AND FEBRUARY 2016. THE PANCREATIC REMNANT WAS CLOSED USING AN ENDOSCOPIC STAPLER OR A COMPETITOR DEVICE. IN ONE GROUP, A REINFORCEMENT FROM ANOTHER MANUFACTURER WAS USED WITH THE STAPLER (56 PATIENTS), IN THE OTHER GROUP THE REINFORCEMENT WAS NOT USED (50 PATIENTS). COMPLICATIONS INCLUDED BLEEDING, ABDOMINAL COLLECTION AND POSTOPERATIVE PANCREATIC FISTULAS. RADIOLOGICAL AND SURGICAL REINTERVENTIONS AND READMISSIONS WERE REPORTED. IT WAS MENTIONED THAT THE PANCREATIC FISTULAS WERE A PROCEDURAL RISK AND THE STUDY RESULTS CONFIRM THAT POSTOPERATIVE PANCREATIC FISTULA CANNOT BE PREVENTED OR REDUCED USING DIFFERENT TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687728 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H