BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1092944 · Received August 1, 2008

    Report

    Report Number
    8010047-2008-00139
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 8, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCI
    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 WS INFORMED THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL THE NEXT DAY AFTER AN ENT PROCEDURE, DUE TO CHEMICAL BURNS ON THE LARYNX. THE USER FACILITY REPORTED THAT FOLLOWING THE EVENT, A SURGICAL TECHNICIAN HAD CHECKED THE DEVICE WITH TEST STRIPS, AND THE BRONCHOSCOPE HAD TESTED POSITIVE FOR PRESENCE OF CIDEX. 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 REFERENCED IN THIS SPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE DEVICE'S INSTRUMENT CHANNEL, SUCTION PROT 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 WILL 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 REPORTED TO THE ED OF THE LOCAL HOSPITAL FOLLOWING AN OUTPATIENT INJECTION OF HIS BILATERAL VOCAL CORDS WITH CALCIUM HYDROXYL APATITE. HE COMPLAINT OF PAIN AND DIFFICULTY SWALLOWING. IN THE SUPRAGLOTTIC AREA AND THE AREA OF THE LARYNGEAL SURFACE OF THE EPIGLOTTIS AND FALSE VOCAL CORDS THERE WAS WHAT APPEARED TO BE AN ESCHAR OR AN EXUDATIVE TYPE ESCHAR THAT WAS WHITISH WITH SOME IRRITATION OF THE TISSUES IN THIS AREA. HE WAS TREATED WITH ANTIBIOTICS, STEROIDS, AND PROTONIX."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| R