BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 11859739 · Received May 20, 2021

    Report

    Report Number
    1717344-2021-00741
    Event Type
    Death
    Date Received
    May 20, 2021
    Date of Event
    June 7, 2020
    Report Date
    May 20, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMPACT OF THE PREOPERATIVE BODY COMPOSITION INDEXES ON INTRAOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING PANCREATODUODENECTOMY SOURCE: SURGERY TODAY (2021) 51:52¿60 PUBLISHED ONLINE: 20 JUNE 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A STUDY RETROSPECTIVELY ANALYZED PATIENTS WHO UNDERWENT PANCREATODUODENECTOMY BETWEEN 2008 AND 2019 TO IDENTIFY SIGNIFICANT PREDICTORS OF BLOOD LOSS. THE LIGASURE WAS THE ONLY DEVICE LISTED AS BEING USED DURING PD. THERE WERE 415 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDE: SEPSIS AND DEATH. CAUSE OF DEATH WAS NOT LISTED AND NOT SPECIFIED IF IT IS DEVICE RELATED. BLOOD TRANSFUSIONS WERE REQUIRED BUT NO OTHER INTERVENTIONS WERE REPORTED. COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDE: PNEUMONIA, DELAYED GASTRIC EMPTYING AND THROMBOTIC/EMBOLIC EVENTS. IMPACT OF THE PREOPERATIVE BODY COMPOSITION INDEXES ON INTRAOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING PANCREATODUODENECTOMY; (YUKIHIRO YOKOYAMA), (2020), (© SPRINGER NATURE SINGAPORE PTE LTD. 2020).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750022 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R