BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1092943 · Received August 1, 2008

    Report

    Report Number
    8010047-2008-00138
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 8, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    CAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, AND WAS INFORMED THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL THE SAME DAY AFTER AN ENT PROCEDURE, DUE TO CHEMICAL BURNS ON THE LARYNX. THE ORIGINAL REPORTING FACILITY HAD BEEN CONTACTED BY THE ADMITTING HOSPITAL, AND INFORMED OF THE ADMISSION. THE ORIGINAL REPORTING FACILITY ATTRIBUTED THE EVENT AS AN ISOLATED INCIDENT AND NO ACTION WAS TAKEN AT THAT TIME. THE FACILITY ALSO REPORTED THAT PRIOR TO THIS EVENT THEY HAD NOT BEEN PERFORMING LEAK TESTS, BUT HAVE NOW IMPLEMENTED THIS PRACTICE. THE FACILITY ALSO NOW USES AN UNSPECIFIED MODEL OF AER TO REPROCESS THE BRONCHOSCOPES, WHEREAS MANUAL REPROCESSING HAD BEEN PREVIOUSLY EMPLOYED. THE PATIENT HAS REPORTEDLY BEEN DISCHARGED FROM THE HOSPITAL, AND WAS SAID TO BE DOING WELL. THE DEVICE REFERENCE IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE DEVICE'S INSTRUMENT CHANNEL, SUCTION PORT AND BIOPSY PORT AND THE DISTAL TIP COVER OPENING WERE EXAMINED, AND AN UNIDENTIFIED WHITE AND YELLOW SUBSTANCE WAS OBSERVED INSIDE THE BRONCHOSCOPE. THERE WAS A LEAK NOTED AT THE BIOPSY CHANNEL AND BENDING SECTION, WHICH WAS ATTRIBUTED TO A CUT/HOLE ON THE BENDING SECTION COVER. THERE WERE SCRAPE AND SHEAR MARKS IN THE BIOPSY CHANNEL AT THE BENDING SECTION AREA. THIS PHENOMENON WAS ATTRIBUTED TO PHYSICAL DAMAGE. THE DEVICE WILL BE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WIL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT WHICH STATED, "PATIENT HAD VOCAL CORD INJECTION AT THE ORIGINAL REPORTING FACILITY IN 2008. FOLLOWING THE PROCEDURE, THE PATIENT HAD EXPERIENCED STRIDOR AND DIFFICULTY BREATHING. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON THE SAME DAY AND A LARYNSCOPIC EXAMINATION WAS PERFORMED. THE EXAMINATION REVEALED SWELLING AND REDNESS AND A PSEUDOMEMBRANE OF THE ARYTENOIDS, GLOTTIS, AND EPIGLOTTIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, STEROIDS AND SUPPLEMENTAL OXYGEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RHINO-LARYNGO VIDEOSCOPE CAL OLYMPUS MEDICAL SYSTEMS CORPORATION ENF-VT2

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention