BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 11167029 · Received January 13, 2021

    Report

    Report Number
    2647580-2021-00138
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    February 20, 2020
    Report Date
    January 13, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: A STUDY INVESTIGATING THE PERFUSION OF COLORECTAL ANASTOMOSES USING FLUORESCENCE ANGIOGRAPHY: RESULTS OF THE FLAG RANDOMIZED TRIAL SOURCE: THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. 22, 1147¿1153 ONLINE PUBLICATION: 20 FEBRUARY 2020. 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 BETWEEN 2018 AND 2019, WHICH EVALUATED THE EFFICACY OF INDOCYANINE GREEN (ICG) FLUORESCENCE ANGIOGRAPHY (FA) IN REDUCING THE INCIDENCE OF ANASTOMOTIC LEAKAGE FOLLOWING STAPLED COLORECTAL ANASTOMOSIS. 377 PATIENTS UNDERWENT SIGMOID AND RECTAL RESECTION AND WERE DIVIDED INTO TWO GROUPS, WITH AND WITHOUT ICG FA. A CIRCULAR STAPLER WAS USED USING A DOUBLE STAPLING TECHNIQUE IN ALL CASES. THE FOLLOWING POST OPERATIVE COMPLICATIONS WERE REPORTED: ANASTOMOTIC LEAKS IN 48 PATIENTS, REOPERATION IN 7 PATIENTS DUE TO ANASTOMOTIC LEAK (6 OF THOSE PATIENTS HAVING ANASTOMOTIC RESECTION AND CREATION OF END COLOSTOMY). THE AVERAGE POSTOPERATIVE LENGTH OF HOSPITAL STAY WAS 8 DAYS. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE WERE; WOUND INFECTION, PARALYTIC ILEUS, URINARY RETENTION, ABDOMINAL BLEEDING AND MECHANICAL ILEUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60414 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R