BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS BRONCHOSCOPE

    MDR report key: 1660863 · Received April 9, 2010

    Report

    Report Number
    8010047-2010-00070
    Event Type
    Other
    Date Received
    April 9, 2010
    Date of Event
    June 18, 2009
    Report Date
    March 11, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT; HOWEVER, THE USER FACILITY PROVIDED ONLY LIMITED INFO. THE HOSP REPORTED THAT THE DEVICE HAD NOT EXPERIENCED A COMPLETE LOSS OF IMAGE, BUT THE USERS HAD EXPERIENCED DIFFICULTY ATTEMPTING TO FOCUS THE IMAGE. THE USER FACILITY ALSO REPORTED THAT A BIOMEDICAL ENGINEER HAD TESTED THE DEVICE FOLLOWING THE EVENT, AND NOT BEEN ABLE TO DUPLICATE THE DIFFICULTY. THE DEVICE WAS NOT RETURNED FOR EVAL, AND WAS SAID TO HAVE BEEN RETURNED TO CLINICAL USE. THE USER FACILITY PROVIDED THE SERIAL # OF THE BRONCHOSCOPE USED DURING THE PROCEDURE BUT DID NOT CONFIRM THE EXACT MODEL OF THE DEVICE. THE SERIAL # PROVIDED CORRESPONDED TO A MODEL BF-240 BRONCHOSCOPE THAT HAD ORIGINALLY BEEN SHIPPED TO A DIFFERENT USER FACILITY IN FEB 2000. THE DEVICE WAS LAST SERVICED BY OLYMPUS IN APR 2002. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE DETERMINED. IF ADDITIONAL INFO BECOMES AVAILABLE LATER, THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH FORM STATING: "EMERGENT BRONCHOSCOPY NECESSARY DURING PERCUTANEOUS TRACH PROCEDURE. BRONCHOSCOPE UNABLE TO FOCUS AFTER USING EVIS 200, INJECTION BUTTONS, WHITE BALANCE, REBOOTING SYSTEM, ATTEMPT TO FOCUS SCOPE ITSELF DID NOT SEEM TO WORK FOR DOCTOR. UNABLE TO VISUALIZE WITH SCOPE, REPLACED WITH ANOTHER SCOPE THAT FIT THE MONITOR AND IT WORKED FINE - ABLE TO CONTINUE THE PROCEDURE, NO HARM TO PT. BIOMED TESTED THE SCOPE FUNCTIONALITY, NO PROBLEM. FOUND SCOPE FOCUSED PROPERLY. CHECKED FOR LEAKS - NONE FOUND. UNIT RETURNED TO SERVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS BRONCHOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP BF-240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR