BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HD ENDOEYE LAPARO-THORACO VIDEOSCOPE

    MDR report key: 4613488 · Received March 16, 2015

    Report

    Report Number
    8010047-2015-00175
    Event Type
    Injury
    Date Received
    March 16, 2015
    Date of Event
    February 20, 2015
    Report Date
    February 23, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. BASED UPON THE EVALUATION OF THE SUBJECT DEVICE BY OMSC, THE PHENOMENON OF NO IMAGE WAS DUPLICATED. THE ELECTRICAL CONNECTOR WAS REPLACED, BUT THE PHENOMENON PERSISTED. IT WAS CONFIRMED THAT A PART OF THE OUTER COVER OF THE IMAGE CABLE WAS TORN AND THE GND WAS EXPOSED. THE GND SHORTED TO THE SHIELD OF THE IMAGE CABLE. FURTHERMORE, THE GND SHORTED TO A METAL PART CALLED "PIPE STOPPER". THE PIPE STOPPER WAS CONNECTED TO THE SHIELD OF THE IMAGE CABLE. WHEN THE GND AND THE PIPE STOPPER WERE SEPARATED, THE IMAGE OUTPUT BECAME BACK TO NORMAL AND VICE VERSA. BASED UPON THE FINDINGS, THE CAUSE OF THE PHENOMENON WAS ATTRIBUTED TO BE THE SHORT CIRCUIT OF THE IMAGE CABLE WHOSE OUTER COVER WAS PARTLY BROKEN. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES RELATED TO THIS PROBLEM NOTED. IN ADDITION, MAINTENANCE HISTORY WAS REVIEWED AND THE SUBJECT DEVICE HAD NOT BEEN SERVICED SINCE (B)(4) 2012 WHEN THE INSERTION TUBE AND THE CONNECTOR WERE CHANGED. SO THE WEAR AND TEAR BY REPEAT USE OR STERILIZATION BY THE USER FACILITY COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR OF THE EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT WHEN THE USER FACILITY SET THE WHITE BALANCE OF THE SUBJECT DEVICE, IMAGE WAS LOST. THEREFORE, THE USER FACILITY SWITCHED THE PROCEDURE FROM THE LAPAROSCOPIC SURGERY TO OPEN SURGERY, AND THEN COMPLETED THE PROCEDURE. IT OCCURRED WHEN THE USER FACILITY FACED THE NECESSITY OF HAVING AN ACUTE SURGERY FOR THE PATIENT. AFTER THE SURGERY, AS A DIFFERENT UNIT OF THE SAME MODEL WAS TESTED TO CONFIRM THAT THE IMAGE OUTPUT WAS FINE WITH NO IRREGULARITY, THE CAUSE OF THE PHENOMENON WAS ASSUMED TO BE THE SUBJECT DEVICE. THE OTHER DEVICE DESCRIBED ABOVE WAS NOT USED FOR THE PROCEDURE, BECAUSE THE DEVICE HAD NOT BEEN STERILIZED AND THERE WAS NO TIME TO STERILIZE TO THE USAGE FOR THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177444 HD ENDOEYE LAPARO-THORACO VIDEOSCOPE LAPARO-THORACO VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORPORATION LTF-VH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other