BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUETTE MULTI-BAND MUCOSECTOMY DEVICE

    MDR report key: 9917203 · Received April 2, 2020

    Report

    Report Number
    3005580113-2020-00343
    Event Type
    Injury
    Date Received
    April 2, 2020
    Report Date
    April 2, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC . PRO CODE: KNS.

    Description of Event or Problem · 1

    THE RATE FOR POST-EMR BLEEDING WAS LOW AT 1.2% PER PATIENT (8 CASES). NO PATIENT BLED MORE THAN ONCE. INTRAPROCEDURAL BLEEDING TREATED BY CLIP PLACEMENT WAS PERFORMED IN 4 (0.6%) SUBJECTS. SEVEN WERE SUCCESSFULLY TREATED WITH ENDOSCOPIC MODALITIES SUCH AS EPINEPHRINE INJECTION, CLIPS, AND THERMAL COAGULATION. ONE PATIENT NEEDED SURGERY TO OVERSEW THE BLEEDING SITE BECAUSE OF UNCONTROLLED BLEEDING THAT DID NOT RESPOND TO EPINEPHRINE INJECTION OR CLIPS. FOUR OF THE CASES PRESENTED WITH A SIGNIFICANT DROP IN HEMOGLOBIN (> 2 MG/DL) FROM BASELINE AND THREE OF THEM REQUIRED BLOOD TRANSFUSIONS. BLEEDING OCCURRED AT A MEAN TIME OF 2.5 DAYS (S.D. 1.5) FROM THE EMR PROCEDURE. INTRAPROCEDURAL BLEEDING TREATED BY CLIP PLACEMENT WAS PERFORMED IN 4 (0.6%) SUBJECTS SEE ABOVE. ONE PATIENT WITH POST-EMR BLEEDING DID NOT TOLERATE PPI THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379073 DUETTE MULTI-BAND MUCOSECTOMY DEVICE KNS COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention