BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 11379692 · Received February 25, 2021

    Report

    Report Number
    1717344-2021-00304
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    June 5, 2016
    Report Date
    February 25, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: COMPARISON OF THE RELIABILITY AND EFFICACY OF DEVICE HEMORRHOIDECTOMY AND A CONVENTIONAL MILLIGAN-MORGAN HEMORRHOIDECTOMY IN THE SURGICAL TREATMENT OF GRADE 3 AND 4 HEMORRHOIDS SOURCE: TURK J SURG 2017; 33: 233-236, DOI: 10.5152/TURKJSURG.2017.3493. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, THE AIM OF THIS STUDY WAS TO COMPARE THE CLINICAL RESULTS OF DEVICE-ASSISTED HEMORRHOIDECTOMY AND MILLIGAN-MORGAN (MM) HEMORRHOIDECTOMY AS A CONVENTIONAL METHOD. PATIENTS WHO UNDERWENT DEVICE-ASSISTED HEMORRHOIDECTOMY OR CONVENTIONAL HEMORRHOIDECTOMY FOR GRADE 3 AND 4 HEMORRHOIDS IN THE CLINIC BETWEEN 2009 AND 2014 WERE INCLUDED IN THIS STUDY. THE PATIENT DATA WERE RETROSPECTIVELY REVIEWED BY SCREENING RECORDS. POST-OPERATIVE BLEEDING OCCURRED IN 24 (12.9%) MM VS 7 (4.7%) DEVICE PATIENTS. PATIENTS WITH EDEMA WERE 1 PER GROUP (0.5% MM VS 0.7% DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275588 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR