BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 4071234 · Received September 2, 2014

    Report

    Report Number
    8010047-2014-00497
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. BASED UPON THE EVALUATION OF THE SUBJECT DEVICE BY OMSC, THE REPORTED IMAGE DIFFICULTIES WAS CONFIRMED. AS A RESULT OF THE EVALUATION, OMSC CONCLUDED THAT THE SIGNAL LINE OF VERTICAL FORWARDING OF THE CCD COMPONENT AND THE EARTH WERE SHORT-CIRCUITED. THERE WAS NO IRREGULARITY IN THE MANUFACTURING RECORD. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEM CORP (OMSC) WAS INFORMED THAT AFTER ANESTHETIZATION TO THE PT, THE USER FACILITY CONNECTED THE SUBJECT DEVICE TO VISERA ELITE SYSTEM, BUT THERE WERE IMAGE DIFFICULTIES. SINCE THE USER FACILITY DID NOT HAVE A BACKUP SCOPE, THEY SWITCHED LAPAROSCOPIC OPERATION TO OPEN ABDOMINAL SURGERY AND COMPLETED THE CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532314 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE LAPAROSCOPE GEI OLYMPUS MEDICAL SYSTEMS CORP LTF-S190-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1