BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLMPUS VIDEO TELESCOPES

    MDR report key: 2980230 · Received February 1, 2013

    Report

    Report Number
    9610773-2013-00021
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 4, 2013
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE REPORTED PHENOMENON OCCURRED DURING A LAPAROSCOPIC PROCEDURE WHERE THE USERS WERE UNABLE TO RESTORE THE IMAGE AFTER IT WENT COMPLETELY BLACK. THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN COMPLETED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND THE IMAGE WITH SPOTTED DARK STAIN THROUGHOUT WITH DISCOLORATION, AND THE IMAGE WAS INTERMITTENT. THE VIDEO CONNECTOR WAS SEVERELY CRACKED AND THE SURFACE OF THE OUTER TUBE WAS NOTED WITH DEEP SCRAPE AND INDENTATION THROUGHOUT. 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 THE IMAGE WENT COMPLETELY DARK DURING AN UNIDENTIFIED PROCEDURE. THERE WAS NO REPORT OF ANY PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45203 OLMPUS VIDEO TELESCOPES TELESCOPE FBP OLYMPUS WINTER & IBE GMBH A50021A NA

    Patients

    Seq Age Sex Outcome Treatment
    1