BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 8794258 · Received July 16, 2019

    Report

    Report Number
    1717344-2019-00904
    Event Type
    Death
    Date Received
    July 16, 2019
    Date of Event
    December 31, 2018
    Report Date
    July 16, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: HAND-ASSISTED LAPAROSCOPIC SPLENECTOMY ADVANTAGES OVER COMPLETE LAPAROSCOPIC SPLENECTOMY FOR SPLENOMEGALY, YONG HUANG, PHD, DECEMBER 31, 2018. WOLTERS KLUWER HEALTH, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED ((B)(6) 2014 AND (B)(6) 2017), LAPAROSCOPIC SPLENECTOMY (LS) IS GENERALLY APPLIED FOR SPLENECTOMY, HOWEVER, IT ALSO BRINGS SOME TECHNICAL CHALLENGES, ESPECIALLY FOR SPLENOMEGALY. HAND-ASSISTED LAPAROSCOPIC SPLENECTOMY (HALS) CAN HELP TO OVERCOME THESE DRAWBACKS WHILE MAINTAINING THE SUPERIORITY OF LS. THIS STUDY WAS AIMED TO EVALUATE THE EFFICACY AND ADVANTAGE OF HALS FOR SPLENOMEGALY. 1 PATIENT DEATH WAS REPORTED DUE TO COMPLICATIONS OF HEMORRHAGIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586785 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death