BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA INSTRUMENT

    MDR report key: 9700844 · Received February 12, 2020

    Report

    Report Number
    1219930-2020-00688
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 3, 2018
    Report Date
    February 12, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: A SINGLE SURGEON¿S EXPERIENCE TRANSITIONING TO ROBOTIC-ASSISTED RIGHT COLECTOMY WITH INTRACORPOREAL ANASTOMOSIS SOURCE: SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2018. RECEIVED: 12 DECEMBER 2017 / ACCEPTED: 3 JANUARY 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, AFTER RIGHT COLECTOMY, POST-OPERATIVE COMPLICATIONS WERE OBSERVED ON FIFTY-FIVE PATIENTS. ONE PATIENT HAD ILEUS, ANOTHER ONE HAD ABSCESS, ONE PATIENT HAD CLOSTRIDIUM DIFFICILE INFECTION, AND ONE PATIENT HAD URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163479 UNKNOWN ENDO GIA INSTRUMENT STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other