BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 11600770 · Received April 1, 2021

    Report

    Report Number
    8010047-2021-04447
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 4, 2021
    Report Date
    May 13, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170339967
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE WITHDRAWAL OF MFR REPORT #8010047-2021-04447 AND CORRECT THE INITIAL REPORT. OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) CONFIRMED THE FOLLOWING FROM THE PHOTOS SENT BY OLYMPUS (THAILAND) CO., LTD. (OTH). THERE WAS A HOLE IN THE GLUE AROUND THE AIR/WATER NOZZLE. THIS WAS A SUPERFICIAL DAMAGE AND DID NOT PENETRATE. SINCE THE HOLE AROUND THE ADHESIVE AT THE DISTAL END WAS NOT PENETRATED AND THE DISTAL END COVER WAS NOT CRACKED, THE CORRECT EVENT WAS NOT THE ADHESIVE GAP BETWEEN THE DISTAL END AND THE PLASTIC COVER, BUT THE SCRATCH ON THE DISTAL END COVER BY THE REPROCESSING EQUIPMENT. THEREFORE, BASED ON THE ABOVE INFORMATION, OLYMPUS RE-EVALUATED THE EVENT REPORTED IN THE INITIAL REPORT AND DETERMINED THAT THE FAILURE MODE IS NOT A MDR REPORTABLE MALFUNCTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO (B)(4) FOR EVALUATION. (B)(4) INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING; THERE WERE A SCRATCH AND A BURN MARK ON THE DISTAL END CAP. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT THERE WAS A HOLE IN THE ADHESIVE AROUND THE PLASTIC COVER AND THERE WAS A GAP IN THE ADHESIVE BETWEEN THE DISTAL END AND THE PLASTIC COVER. THE DEVICE WAS A DEMONSTRATION MACHINE AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498865 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170339967

    Patients

    Seq Age Sex Outcome Treatment
    1