BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 10714733 · Received October 21, 2020

    Report

    Report Number
    1717344-2020-01252
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    August 26, 2020
    Report Date
    October 21, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: SAFETY AND EFFICACY OF USING STAPLERS AND VESSEL SEALING DEVICES FOR LAPAROSCOPIC SPLENECTOMY: A RANDOMIZED CONTROLLED TRIAL SOURCE: SURGICAL INNOVATION 2020, VOL. 0(0) 1¿6 © THE AUTHOR(S) 2020 ARTICLE REUSE GUIDELINES: SAGEPUB.COM/JOURNALS-PERMISSIONS DOI: 10.1177/1553350620953023 JOURNALS.SAGEPUB.COM/HOME/SRI. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, THIS STUDY COMPARES THE SAFETY AND EFFICACY OF USING ENDOSCOPIC STAPLERS AND VESSEL SEALING DEVICES TO CONTROL THE SPLENIC PEDICLE IN PATIENTS WITH NON SEVERE SPLENOMEGALY. A TOTAL OF 51 PATIENTS WITH DIFFERENT BLOOD DISORDERS INCLUDING IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP), HYPERSPLENISM, AND LYMPHOMA WERE RANDOMIZED FOR ELECTIVE LAPAROSCOPIC SPLENECTOMY. THERE WERE TOTAL OF 25 CASES IN THE LIGASURE GROUP AND 26 PATIENTS IN THE STAPLER GROUP. INTRAOPERATIVE COMPLICATIONS OCCURRED IN 6 CASES. IN THE LIGASURE GROUP, 4 PATIENTS HAD UNCONTROLLABLE BLEEDING LEADING TO CONVERSION TO LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175608 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention