BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS VIDEO UPPER ENDOSCOPE

    MDR report key: 781277 · Received June 21, 2006

    Report

    Report Number
    MW1040993
    Event Type
    Injury
    Date Received
    June 21, 2006
    Date of Event
    November 8, 2005
    Report Date
    June 21, 2006
    Manufacturer
    OLYMPUS AMERICA
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HYPOPHARYNGEAL TEAR RELATED TO UPPER ENDOSCOPY. SMALL CONTAINED LEAK PROMPTLY RECOGNIZED AND DIAGNOSED BY GASTROGRAFFIN SWALLOW STUDY. SUBJECT MADE NPO, IV FLUIDS AND ANTIBIOTICS WERE ADMINISTERED. SUBJECT WAS ADMITTED FOR SUPPORTIVE MANAGEMENT AND RELEASED W/ NO COMPLICATIONS 3 DAYS LATER. SAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEO UPPER ENDOSCOPE OLYMPUS VIDEO UPPER ENDOSCOPE KOG OLYMPUS AMERICA GIF-0180 *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization