BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS LIGHT SOURCE

    MDR report key: 2000386 · Received February 9, 2011

    Report

    Report Number
    8010047-2011-00023
    Event Type
    Other
    Date Received
    February 9, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 11, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT. THE BIOMED REPORTED THAT THE USER HAD MADE AN UNSPECIFIED ERROR DURING THE PROCEDURE. THE STAFF FURTHER REPORTED THAT AFTER PERFORMING THE CT SCAN, THE PT WAS TAKEN TO THE INTENSIVE CARE UNIT. THE PT WAS ORIGINALLY ADMITTED TO THE HOSPITAL ON (B)(6) 2011, AND WAS DISCHARGED IN A STABLE CONDITION ON (B)(6) 2011. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS SUBJECTED TO EXTENDED OPERATION, BUT NO ANOMALIES WERE NOTED WITH THE AIR DELIVERY FROM THE SUBJECT DEVICE. THE AIRFLOW WAS TESTED AND DETERMINED TO BE CONSISTENT. THE EVALUATION DID NOT OBSERVE ANY ABNORMAL AIR SUPPLY DURING THE EVALUATION OF THE DEVICE. THE AIR PIPE JOINT WAS INSPECTED AND NO ANOMALIES WERE DETECTED. THE FRONT PANEL WAS NOTED TO BE WORN AND THERE WERE STAINS ON SOME OF THE LABELS. THE PINS ON THE CONNECTOR SHOWED EVIDENCE OF WEAR ON THE CONNECTOR SOCKET, AND CORROSION ON SOME OF THE ELECTRICAL CONNECTOR PINS. THE DEVICE WAS SERVICED AND WAS RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE USER FELT RESISTANCE WITH THE LIGHT SOURCE AIR DELIVERY AND, THEN DELIVERED MORE AIR. THE PT'S BLOOD PRESSURE AND HEART RATE REPORTEDLY THEN INCREASED DRAMATICALLY. THE USER ELECTED TO REMOVE THE UNIDENTIFIED MODEL OF ENDOSCOPE FROM THE PT AND ABORTED THE PROCEDURE. THE USER REPORTEDLY BELIEVED THAT THE ABDOMINAL WALL HAD STRIATIONS AND POSSIBLE PERFORATION. A CT SCAN WAS PERFORMED AND WAS SAID TO SHOW NO CONFIRMATION OF STRIATIONS AND PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS LIGHT SOURCE LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEM CORPORATION CLV-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R TO HAVE BEEN USED DURING THE PROCEDURE| UNKNOWN MODEL/SERIAL NUMBER OF ENDOSCOPE WAS SAID