BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 10783838 · Received November 4, 2020

    Report

    Report Number
    1219930-2020-04678
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    April 23, 2020
    Report Date
    November 4, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ENDOSCOPIC MANAGEMENT OF POSTOPERATIVE ANASTOMOTIC BLEEDING IN PATIENTS WITH COLORECTAL CANCER SOURCE: INTERNATIONAL JOURNAL OF COLORECTAL DISEASE (2020) 35:1703¿1709 / PUBLISHED ONLINE: 26 MAY 2020. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE REPORT, A RETROSPECTIVE STUDY EVALUATED THE ANASTOMOTIC BLEEDING OF PATIENTS WITH COLORECTAL CANCER BETWEEN JULY 2013 AND SEPTEMBER 2019. COLONOSCOPIES WERE PERFORMED IN 78 PATIENTS. POST-OPERATIVELY, ANASTOMOTIC LEAKAGE OCCURRED IN 8 PATIENTS. IT WAS ALSO REPORTED THAT HEMOCLIP WERE USED AND WERE SUCCESSFUL IN 7 OUT OF THE 8 PATIENTS. TITLE OF THE ARTICLE: ENDOSCOPIC MANAGEMENT OF POSTOPERATIVE ANASTOMOTIC BLEEDING IN PATIENTS WITH COLORECTAL CANCER AUTHORS: LIU W., LIN D., ZHONG Q. YEAR: 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249781 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention