BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 10146931 · Received June 12, 2020

    Report

    Report Number
    8010047-2020-03299
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Date of Event
    May 14, 2020
    Report Date
    February 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    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 REPORT THE WITHDRAWAL OF MFR REPORT #8010047-2020-03299 WHICH WAS SUBMITTED ON JUN 12, 2020. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THAT THERE ARE NO MALFUNCTION OR ADVERSE EVENTS THAT REQUIRE THE MDR REPORT ABOUT THIS EVENT.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS BEEN NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (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

    THE REPAIR CENTER OF OLYMPUS (B)(4) WAS INFORMED FROM THE USER THAT THE IMAGE OF THE SUBJECT DEVICE WAS DISAPPEARED BUT RED DOTS WERE APPEARED DURING THE LAPAROSCOPIC CHOLECYSTECTOMY. THE USER CHANGED THE ENDOSCOPIC SYSTEM TO ANOTHER AND COMPLETED THE PROCEDURE. AT THE INSPECTION FOR THE REPAIR, THE REPAIR CENTER OF OLYMPUS (B)(4) IDENTIFIED THE NOISE OCCURRED ON THE IMAGE OF THE SUBJECT DEVICE. IT WAS ALSO FOUND THAT ITS VIDEO CONNECTOR SOCKET WAS LOOSEN MUCH. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT. IT WAS NOT PROVIDED THE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611152 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1