BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 10797876 · Received November 6, 2020

    Report

    Report Number
    8010047-2020-08605
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Report Date
    January 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. SINCE THE DEVICE WAS NOT RETURNED, THE EXACT CAUSE WAS UNKNOWN. BASED UPON THE INFORMATION FROM COMPLAINT, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED DUE TO THE OP-AMP OF THE CIRCUIT BOARD OF THE DEVICE WAS BROKEN. THE OP-AMP'S FAILURE WAS ATTRIBUTED TO A DESIGN-RELATED MALFUNCTION AND THE CIRCUIT BOARD WAS CORRECTED. THE DEVICE IN THIS EVENT HAD BEEN MANUFACTURED BEFORE THE CORRECTION WAS IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT WHEN THE CUSTOMER PLUGGED AN OLYMPUS 180 SERIES ENDOSCOPE INTO THIS DEVICE, THE MONITOR DISPLAYED INCOMPLETE ENDOSCOPIC IMAGE AND THEN PIXEL DOTS APPEARED. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268171 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1