BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS TRACHEAL INTRUBATION FIBERSCOPE

    MDR report key: 2619020 · Received June 7, 2012

    Report

    Report Number
    8010047-2012-00184
    Event Type
    Other
    Date Received
    June 7, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 9, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE INFO REGARDING THE REPORT AND WAS INFORMED THAT THE LOANER DEVICE DID NOT FIT THE 37 FR (12.3 MM) ETT, AND AS A RESULT THE PT PROCEDURE WAS CONVERTED TO AN OPEN SURGERY. HOWEVER, A REVIEW OF THE ENDOSCOPE SPECIFICATION SHOWED THAT THE DISTAL END OUTER DIAMETER OF THE SCOPE IS 5.1 MM WHICH IS MUCH SMALLER THAN THE ETT THAT THE USER CLAIMED TO USE WITH THE DEVICE; THUS THE SCOPE SHOULD HAVE FIT PERFECTLY INTO THE ETT. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE EVALUATION REVEALED A MINOR DENT ON THE INSERTION TUBE, AND THE IMAGE TILT WAS SLIGHTLY OFF. THE DEVICE PASSED THE LEAK TEST. THIS DEVICE WILL BE SERVICED AND RETURNED TO STOCK. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE DETERMINED BUT USER MISHANDLING COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN A EXCESS OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A LOANER DEVICE WAS USED ON A PROCEDURE TO REPAIR ATRIAL SEPTAL DEFECT; HOWEVER, THE DEVICE DID NOT FIT INTO A 37 FRENCH ENDOTRACHEAL TUBE (EIT) MADE BY (B)(4). THE PT WAS SAID TO HAVE BEEN SEDATED, AS A RESULT AN OPEN SURGERY (STERNOTOMY) WAS PERFORMED ON THE PT TO PLACE THE BRONCHO CAP. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS TRACHEAL INTRUBATION FIBERSCOPE INTUBATION FIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORPORATION LF-TP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK