BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 10797044 · Received November 5, 2020

    Report

    Report Number
    8010047-2020-08599
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    January 14, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. BASED ON THE INFORMATION THAT THE VIDEO CONNECTOR SOCKET WAS DAMAGED AND RUSTED, OMSC HAS CONCLUDED THAT THE EFFECTS OF DAMAGE AND RUST MAY HAVE DESTABILIZED VIDEO TRANSMISSION BETWEEN THE ENDOSCOPE AND THE VIDEO SYSTEM CENTER, RESULTING IN IMAGE MALFUNCTION SUCH AS IMAGE FLICKER AND NOISE. AND IT WAS CONSIDERED THAT THE CONNECTION STATE BETWEEN THE ENDOSCOPE AND THE VIDEO SYSTEM CENTER CHANGED DUE TO THE INSERTION AND REMOVAL OF THE ENDOSCOPE AND THE ENDOSCOPIC IMAGE WAS SOMETIMES DISPLAYED PROPERLY. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO CORRECT INFORMATION PROVIDED ON THE PREVIOUS REPORTS. THE FOLLOWING SECTIONS WERE UPDATED AND/OR CORRECTED: D4, D5, D10, G4, G7, H2, H3, H6 AND H10.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS IBERIA S.A.U. (OIB) FOR EVALUATION. THE EVALUATION OF THE DEVICE BY OIB CONFIRMED THE FOLLOWING; THE VIDEO CONNECTOR SOCKET OF THE DEVICE WAS DAMAGED AND RUSTED, AND THE TERMINAL WAS CORRODED. THE REPORTED EVENT APPEARED TO BE CAUSED BY TERMINAL CORROSION OF THE VIDEO CONNECTOR SOCKET. 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

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE ENDOSCOPIC IMAGE OF THE DEVICE WAS NOT DISPLAYED DURING VIDEO-ASSISTED THORACIC SURGERY. THE CUSTOMER WAS USING THE SDI SIGNAL. THE USER DID NOT REPLACE THE DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256572 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ OLYMPUS MEDICAL SYSTEMS CORP. CV-180

    Patients

    Seq Age Sex Outcome Treatment
    1