BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 307871 · Received December 6, 2000

    Report

    Report Number
    8010047-2000-00096
    Event Type
    Injury
    Date Received
    December 6, 2000
    Report Date
    November 7, 2000
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    FAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION: AN OFFICE PHYSICIAN REPORTED THAT FOUR PTS EXPERIENCED DISCOMFORT AND SYMPTOMS OF COLITIS FOLLOWING SIGMOIDOSCOPY PROCEDURES. MEDICAL TREATMENT WAS REQUIRED FOR THE FOUR ILL PTS. NOTE: WHEN THE OLYMPUS TECHNICAL SERVICE SUPERVISOR VISITED THE OFFICE ON 11/07/2000, THE PHYSICIAN EXPLAINED THAT OSF-3 WAS USED FOR THE SIGMOIDOSCOPY PROCEDURES ASSOCIATED WITH PT INFECTIONS. ON OR ABOUT 11/28/2000, OSF-3 WAS DELIVERED TO THE OLYMPUS REPAIR CENTER. THE PHYSICIAN NOTIFIED THE SUPERVISOR THAT THE FIRST OSF-3 WAS NOT RELATED TO THE INFECTIONS AS INITIALLY REPORTED. SOME DETAILS OF THE INITIAL VISIT AND INVESTIGATION OF OSF-3 ARE BEING PROVIDED AS BACKGROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SIGMOIDOSCOPE FAM OLYMPUS OPTICAL CO. LTD. OSF-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention