BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 2123529 · Received June 9, 2011

    Report

    Report Number
    8010047-2011-00118
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT BUT WAS NOT PROVIDED ANY FURTHER INFORMATION. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. APPROXIMATELY 30MM OF THE INSERTION TUBE HAD BEEN TORN OFF FROM THE DISTAL END. INTERNAL ELEMENTS OF THE ENDOSCOPE, INCLUDING LIGHT GUIDE CABLE IN INSTRUMENT CHANNEL, WERE EXPOSED AT THE END OF THE INSERTION TUBE THAT REMAINED CONNECTED TO THE CONTROL BODY. ADDITIONALLY, THE BENDING SECTION SKELETON WAS NOTED DEFORMED, AND THE INSERTION TUBE WAS DENTED AND BUCKLED. BASED UPON THE FINDINGS OF THE INVESTIGATION, IT APPEARS THAT THE DISTAL END OF THE DEVICE WAS TORN FROM THE INSERTION TUBE, LIKELY WHEN THE ENDOSCOPE BECAME ENTRAPPED ON SOME UNKNOWN OBJECT AND WAS SUBJECTED TO EXTREME PHYSICAL FORCE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE TIP OF THE SUBJECT DEVICE FELL INTO THE PATIENT. THE TIP WAS REPORTEDLY SUCTIONED OUT FROM THE PATIENT. THE PATIENT WAS REPORTEDLY UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION FIBERSCOPE EQN OLYMPUS MEDICAL SYSTEM CORPORATION LF-GP NA

    Patients

    Seq Age Sex Outcome Treatment
    1