BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 12596561 · Received October 8, 2021

    Report

    Report Number
    8010047-2021-12902
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 11, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE FOLLOWING INFORMATION, OMSC PRESUMED THE CAUSE OF THE EVENT WAS THAT THE INJECTION TUBE OR SILICONE RUBBER PRODUCTS USED IN THE ENDOSCOPY ROOM ACCIDENTALLY WENT INSIDE. ACCORDING TO THE INSPECTION RESULTS OF THE DEVICE, THERE WAS A BROWN FOREIGN MATERIAL WHOSE TEXTURE WAS KIND OF SOFT IN THE NOZZLE. IFU STATES THE FOLLOWING DESCRIPTION. DURING REPROCESSING, FEED WATER TO THE AIR/WATER CHANNEL TO CLEAR THE BLOCKAGE. USE A SPONGE OR GAUZE TO CLEAN DISTAL END, WITH CARE TO THE NOZZLE OPENING. ACCORDING TO THE SIMILAR COMPLAINT, A PART OF THE INJECTION TUBE OR SILICONE RUBBER PRODUCTS USED IN THE ENDOSCOPY ROOM ACCIDENTALLY GOT INTO THE AIR/WATER CHANNEL.

    Additional Manufacturer Narrative · 0

    LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THE PHENOMENON. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT LOCAL SERVICE DEPARTMENT OF OLYMPUS, IT WAS FOUND THAT THE NOZZLE HAD A BROWN FOREIGN MATERIAL WHOSE TEXTURE WAS KIND OF SOFT AND WAS CLOGGED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498213 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H260AI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown