BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HET

    MDR report key: 12735899 · Received November 2, 2021

    Report

    Report Number
    1717344-2021-01491
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    July 19, 2021
    Report Date
    November 2, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884521511132
    PMA / PMN Number
    K140422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: PROSPECTIVE EVALUATION OF THE HEMORRHOID ENERGY TREATMENT FOR THE MANAGEMENT OF BLEEDING INTERNAL HEMORRHOIDS SOURCE: HTTPS://WWW.F6PUBLISHING.COM WORLD J GASTROINTEST ENDOSC 2021 AUGUST 16; 13(8): 329-335 DOI: 10.4253/WJGE.V13.I8.329 ISSN 1948-5190 (ONLINE). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO A LITERATURE, A PROSPECTIVE STUDY EVALUATED THE OUTCOMES OF PATIENTS WITH GRADE I OR II INTERNAL HEMORRHOIDS WHO UNDERWENT HEMORRHOID ENERGY TREATMENT FROM (B)(6) 2016 TO (B)(6) 2019. THE HET BIPOLAR SYSTEM WAS USED IN ALL PATIENTS. THERE WERE 73 PATIENTS IN THE STUDY AND POSTOPERATIVE COMPLICATIONS INCLUDED PERSISTENT RECTAL BLEEDING. SIX PATIENTS REQUIRED A SECOND PROCEDURE DUE TO BLEEDING. THREE PATIENTS HAD PERSISTENT BLEEDING AFTER REPEAT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633457 HET ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER 180-1022 10884521511132

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention