BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 14635044 · Received June 8, 2022

    Report

    Report Number
    1717344-2022-00702
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    April 24, 2022
    Report Date
    June 8, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: A SINGLE CENTER RETROSPECTIVE COMPARISON OF POST-TONSILLECTOMY HEMORRHAGE BETWEEN BIZACT AND COBLATOR SOURCE: INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY 158 (2022) 111165. 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 EXAMINED THE RATE OF POST-OPERATIVE HEMORRHAGE REQUIRING CONTROL OF HEMOSTASIS IN THE OPERATING ROOM IN PEDIATRIC PATIENTS UNDERGOING TONSILLECTOMY BETWEEN JANUARY 2018 AND DECEMBER 2020. TONSILLECTOMY WAS PERFORMED UTILIZING HOT TECHNIQUE WITH BIZACT VS. A COMPETITOR PRODUCT. THERE WERE 1384 PATIENTS INCLUDED IN THE STUDY; 444 PATIENTS UNDERWENT BIZACT TONSILLECTOMY AND 11 PATIENT EXPERIENCED POST-TONSILLECTOMY HEMORRHAGE WHICH REQUIRED CONTROL OF HEMORRHAGE IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144980 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Unknown Required Intervention