BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1052379 · Received May 23, 2008

    Report

    Report Number
    9610773-2008-00016
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DUPLICATE THE USER'S REPORT OF A COMPLETE LOSS OF IMAGE. HOWEVER, THE IMAGE WAS OBSERVED TO BE SLIGHTLY DARK, AND THE UNIT FAILED THE LIGHT TRANSMISSION TEST. THE INVESTIGATION NOTED LARGE DENTS ON THE OUTER TUBE. ADDITIONALLY, DENTS WERE NOTED ON THE LIGHT GUIDE ADAPTER AND VIDEO CONNECTOR PLUG AND SCRATCHES WERE FOUND ON THE OUTER TUBE, DISTAL END, AND VIDEO CONNECTOR PLUG. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, THE PHYSICAL DAMAGE FOUND ON THE DEVICE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT. THIS REPORT IS BEING FILED AS MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPY, A COMPLETE LOSS OF IMAGE WAS EXPERIENCED. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEO TELESCOPE FBP OLYMPUS WINTER & IBE GMBH WA50011A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK