BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 11391303 · Received March 1, 2021

    Report

    Report Number
    8010047-2021-03115
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 4, 2021
    Report Date
    April 26, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT H3 IN THE INITIAL REPORT AND REPORT THE ADDITIONAL INFORMATION. CORRECTION ON H3 "EVALUATION SUMMARY ATTACHED" WAS MADE AS FOLLOW. BLANK TO CHECK. THE ADDITIONAL INFORMATION WAS AS FOLLOW. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE DEVICE WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) ASSUMED THAT THE REPORTED EVENT WAS CAUSED BY A DAMAGED DVI PORT. THIS DAMAGED DVI PORT MAY HAVE BEEN CAUSED BY STRESS DUE TO HANDLING. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND FOLLOWINGS; DVI PORTS D1 AND D2 WERE DAMAGED AS REPORTED. THERE WERE DENTS AND SCRATCHES ON THE BEZEL. THERE WAS A SCRATCH ON THE FRONT PROTECTIVE PANEL. THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN IDENTIFIED BY LEGAL MANUFACTURER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THIS DEVICE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE DEVICE HAD BEEN SENT TO BIOMEDICAL ENGINEERING AT THE USER FACILITY FOR INSPECTION. THEY FOUND THAT THE DEVICE WAS EXPERIENCING AN INTERMITTENT ENDOSCOPIC IMAGE. THEY ASSUMED THAT THE PHENOMENON WAS CAUSED BY A DAMAGED DVI PORT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291063 HIGH DEFINITION LCD MONITOR MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV261H

    Patients

    Seq Age Sex Outcome Treatment
    1