BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 315360 · Received February 6, 2001

    Report

    Report Number
    MW1021027
    Event Type
    Malfunction
    Date Received
    February 6, 2001
    Report Date
    February 6, 2001
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OLYMPUS OSF-2 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPES ARE NO LONGER "STANDARD OF CARE" BECAUSE THE SIGMOIDOSCOPE CANNOT BE CLEANED PROPERLY - ACCORDING TO THE MFR. THERE IS THE POTENTIAL OF PATIENT-TO-PATIENT CONTAMINATION. HOWEVER, OLYMPUS HAS NOT ISSUED A WARNING ON RECALL TO THOSE WHO PURCHASED THERE SCOPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4483 OLYMPUS OSF-2 FLEXIBLE SIGMOIDOSCOPE FAM OLYMPUS AMERICA, INC. OSF-2 *
    4484 OLYMPUS OSF-2 FLEXIBLE SIGMOIDOSCOPE FAM OLYMPUS AMERICA, INC. OSF-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other