BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 11468230 · Received March 11, 2021

    Report

    Report Number
    8010047-2021-03620
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Report Date
    April 21, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    PMA / PMN Number
    K111756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 TRANSMISSION FAILURE BETWEEN THE ENDOSCOPE AND THE VIDEO PROCESSOR DUE TO THE DEFECT OF VIDEO CONNECTOR SOCKET. THIS DEFECT MAY HAVE BEEN CAUSED BY LONG-TERM USE. 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 MEDICAL SYSTEMS (B)(4) AND FOUND FOLLOWINGS; THE REPORTED EVENT WAS REPRODUCED. THERE WAS NOISE WHEN THE ENDOSCOPE WAS CONNECTED TO THE DEVICE. AND THERE WAS NO ENDOSCOPIC IMAGE. (B)(4) SAID THIS PHENOMENON WAS DUE TO A DEFECTIVE RECEPTACLE UNIT. THERE WAS A CRACK IN THE POWER SWITCH. DUE TO THIS FAILURE, THE POWER SWITCH STUCK AND THE DEVICE COULD NOT BE TURNED OFF. THERE WERE SMALL SCRATCHES ON THE TOP COVER, CHASSIS AND FRONT PANEL. THERE WAS RUST ON THE TOP COVER AND REAR PANEL. THE TANK SOCKET WAS DEFORMED. 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

    A CUSTOMER REPORTED THAT NO ENDOSCOPIC IMAGE WAS DISPLAYED WHEN THE ENDOSCOPE WAS CONNECTED TO THE DEVICE. HORIZONTAL LINES WERE DISPLAYED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355268 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FDF OLYMPUS MEDICAL SYSTEMS CORP. CV-V1

    Patients

    Seq Age Sex Outcome Treatment
    1