BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 2971796 · Received February 10, 2013

    Report

    Report Number
    2971796
    Event Type
    Malfunction
    Date Received
    February 10, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 8, 2013
    Manufacturer
    OLYMPUS AMERICA, INC
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    MEDICAL ASSISTANT WORKING IN BRONCHOSCOPY PROCEDURE ROOM OBSERVED WHAT APPEARED TO BE FOREIGN SUBSTANCE STAINING INSIDE OF STAINLESS STEEL BIOPSY PORT RESERVOIR OF BRONCHOSCOPE. DARK RED RESIDUE CAME OFF ON COTTON-TIPPED APPLICATOR. UPON EXAMINING ENTIRE INVENTORY OF BRONCHOSCOPES IN MPU (MEDICAL PROCEDURE UNIT), SIMILAR RESIDUE/STAINING WAS DISCOVERED IN FIVE (5) OTHER BRONCHOSCOPES. THE INITIAL BRONCHOSCOPE WAS REWASHED AND HIGH-LEVEL DISINFECTED; AND HAD NO FURTHER VISIBLE RESIDUE/STAINING AFTER SAME. IT WAS PUT BACK INTO CIRCULATION. THE REMAINING FIVE SCOPES WERE SEQUESTERED FOR MANAGEMENT FOLLOW-UP. AFTER ADDITIONAL REPROCESSING, ONLY ONE OF THE FIVE BRONCHOSCOPES HAD NO FURTHER VISIBLE RESIDUE/STAINING. REPORTER VALIDATED THAT THE CORRECT BRUSH IS BEING USED IN POST-PROCEDURE MANUAL CLEANING PROCESS; AND THAT STAFF VERBALIZED APPROPRIATE STEPS OF MANUAL CLEANING PROCESS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BRONCHOSCOPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57965 OLYMPUS BRONCHOSCOPE (FLEXIBLE OR RIGID) KOG OLYMPUS AMERICA, INC BF-UC180 UNK
    57966 OLYMPUS BRONCHOSCOPE (FLEXIBLE OR RIGID) KOG OLYMPUS AMERICA, INC. BF-UC180 UNK
    57967 OLYMPUS BRONCHOSCOPE (FLEXIBLE OR RIGID) KOG OLYMPUS AMERICA, INC. BF1T180 UNK
    57968 OLYMPUS BRONCHOSCOPE (FLEXIBLE OR RIGID) KOG OLYMPUS AMERICA, INC. BF1T180 UNK
    57969 OLYMPUS BRONCHOSCOPE (FLEXIBLE OR RIGID) KOG OLYMPUS AMERICA, INC. BF3C160 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *