BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS TELESCOPES

    MDR report key: 2072813 · Received March 31, 2011

    Report

    Report Number
    9610773-2011-00010
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO GATHER ADD'L INFO REGARDING THIS REPORT VIA PHONE AND IN WRITING WITHOUT SUCCESS. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND THE OUTER TUBE WAS CRITICALLY BENT BY THE DIRECTION PIN. THERE WERE MINOR SCRATCHES AND DENT MARKS AROUND THE DISTAL TIP AND ON THE OBJECTIVE FRAME. ADDITIONALLY, IT WAS NOTED THAT THE OPTICAL LENS WAS BROKEN. THE CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THERE WAS A POPPING SOUND AND THE IMAGE WENT BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS TELESCOPES TELESCOPE FBP OLYMPUS WINTER & IBE GMBH A22001A NA

    Patients

    Seq Age Sex Outcome Treatment
    1