BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 11176969 · Received January 15, 2021

    Report

    Report Number
    8010047-2021-01473
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 21, 2020
    Report Date
    February 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION,, BUT WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ). DURING THE INCOMING INSPECTION, OAZ FOUND NO AIR LEAK FROM THE INSTRUMENT CHANNEL, ADHESIVE DETACHMENT AT THE OF BENDING RUBBER, INSUFFICIENT BENDING ANGLE, AND SO ON. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE IS A POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO INSUFFICIENT REPROCESSING DUE TO ACCIDENTAL INADEQUATE REPROCESSING OR THE DEVICE DAMAGES.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS BEEN NOT RETURNED TO OMSC FOR THE EVALUATION, 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 MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FORM THE USER THAT THE BLOOD CAME OUT FROM THE SUBJECT DEVICE AT THE NEXT DAY WHEN THE SUBJECT DEVICE HAD BEEN USED AND REPROCESSED WITH THE CLEANING BRUSH AND A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE, THEN PUT INTO THE DRYING CABINET. IT WAS NOT PROVIDED OTHER DETAILED INFORMATION. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73555 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1