BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA PRO VIDEO SYSTEM CENTER

    MDR report key: 11491212 · Received March 16, 2021

    Report

    Report Number
    8010047-2021-03764
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 19, 2021
    Report Date
    April 22, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K062049
    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 UNSTABLE TRANSMISSION BETWEEN CAMERA HEAD AND VIDEO PROCESSOR DUE TO POOR VIDEO CONNECTOR PIN CONTACT. THIS POOR CONTACT MAY HAVE BEEN CAUSED BY WEAR DUE TO 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) PRIVATE LIMITED AND FOUND FOLLOWINGS; THE ENDOSCOPIC IMAGE FLICKERED DUE TO A FAILURE OF THE RECEPTACLE UNIT. THE PRINTED CIRCUIT BOARD WAS DAMAGED. THERE WAS DUST INSIDE THE DEVICE. THERE WERE MINOR DENTS AND SCRATCHES ON THE TOP COVER, FRONT PANEL AND REAR PANEL. THERE WAS RUST ON THE REAR PANEL CONNECTOR. THE BOARDS WERE SEVERELY CORRODED, BUT ALL BOARDS WERE FUNCTIONING NORMALLY AT THE TIME OF INSPECTION. THE PAINT ON THE TOP COVER HAD PEELED OFF. THERE WAS SEVERE CORROSION ON THE CHASSIS. 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 THE ENDOSCOPIC IMAGE FLICKERED DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389107 VISERA PRO VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PRO

    Patients

    Seq Age Sex Outcome Treatment
    1