BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 910201 · Received September 11, 2007

    Report

    Report Number
    8010047-2007-00130
    Event Type
    Malfunction
    Date Received
    September 11, 2007
    Date of Event
    August 10, 2007
    Report Date
    August 29, 2007
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION DID NOT CONFIRM THE PRESENCE OF BLOOD IN THE BIOPSY CHANNEL. THE ENDOSCOPE WAS BRUSHED WITH TWO DIFFERENT BRUSHES TO CHECK FOR THE PRESENCE OF BLOOD INSIDE THE CHANNEL, BUT NONE WAS NOTED. THE ENDOSCOPE'S BIOPSY CHANNEL WAS EXAMINED AND FOUND EVIDENCE OF SCRAPE MARKS IN THE CHANNEL WALL APPROXIMATELY 87 CM FROM THE DISTAL END. THESE SCRAPE MARKS WERE ATTRIBUTED TO PHYSICAL DAMAGE FROM AN ENDOTHERAPY DEVICE. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME, HOWEVER, USER HANDLING AND INADEQUATE CLEANING OF THE CHANNELS CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE USER'S EXPERIENCE. THE DEVIE WAS SERVICED AND RETURNED TO THE CUSTOMER, AND THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION. IF ADD'L RELEVANT INFO BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    IN 2007, A MEDWATCH REPORT WAS RECEIVED FROM THE USER FACILITY. THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC ULTRASOUND PROCEDURE, THE ENDOSCOPE HAD NO AIR AND LIMITED WATER. THE ENDOSCOPE WAS THEN WITHDRAWN FROM THE PT, AND THE ENDOSCOPE TECH TRIED TO FLUSH OUT THE ENDOSCOPE'S CHANNEL TO REGAIN THE AIR/WATER FLOW, DURING WHICH WHAT APPEARED TO BE BLOODY DRAINAGE WAS NOTED. THE USER FACILITY REPORTED THAT THE PROCEDURE PERFORMED ON THE PT AT THE TIME DID NOT INVOLVE BLOOD LOSS. THE FACILITY WAS CONTACTED FOR ADD'L INFO REGARDING THIS REPORT. ACCORDING TO THE DATA ANALYST THERE WAS NO CROSS CONTAMINATION ASSOCIATED WITH THIS EVENT, AND NO ADD'L TESTING OR TREATMENT WAS PROVIDED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ULTRASONIC GASTRO VIDEOSCOPE GCK OLYMPUS OPTICAL CO. LTD. GF-UCT140-A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR