BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 11926833 · Received June 3, 2021

    Report

    Report Number
    8010047-2021-07024
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    July 9, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K122831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS KOREA CO., LTD. (OKR) FOR EVALUATION. OMSC DETERMINED THAT ERROR E110 WAS CAUSED BY A TEMPORARY MALFUNCTION BECAUSE IT DID NOT RECUR DURING THE INSPECTION BY OKR. ERROR E110 MEANS THAT THE OPTICAL FILTER HAS FAILED, AND A TEMPORARY MALFUNCTION MAY HAVE OCCURRED DUE TO DETERIORATION OF THE SOLENOID DUE TO REPEATED USE FOR A LONG PERIOD OF TIME, BECAUSE MORE THAN FIVE AND A HALF YEARS HAVE PASSED SINCE THE DEVICE WAS MANUFACTURED. OMSC DETERMINED THAT ALL FRONT PANEL LED DIODE FAILURES WERE CAUSED BY THE USER. IT WAS NOT CONFIRMED DURING THE INSPECTION OF THE DEVICE BY OKR, BUT FROM THE PHOTOS PROVIDED BY OKR, OMSC CONFIRMED THAT THERE WERE CHEMICAL MARKS ON THE FRONT PANEL. ALL LED DIODES ON THE FRONT PANEL MAY HAVE FAILED DUE TO THE USER POURING LIQUID ON THE DEVICE. IN ADDITION, IT IS POSSIBLE THAT THE ENDOSCOPE IMAGE WAS NOT DISPLAYED BECAUSE THE CONNECTION PART OF THE VIDEO CONNECTOR SOCKET WAS WORN AND LOOSENED DUE TO THE FORCIBLE ATTACHMENT OR DETACHMENT OF THE ENDOSCOPE CONNECTOR. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. 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 · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO (B)(4) FOR EVALUATION. (B)(4) INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: THE PHENOMENON REPORTED BY THE USER COULD NOT BE REPRODUCED. THE OUTPUT SOCKET WAS LOOSE. 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 BY THE USER THAT DURING THE PREPARATION FOR USE, THE ERROR E110 OCCURRED INDICATING THAT THE OPTICAL FILTER WAS DAMAGED. THIS ERROR E110 IS CAUSED BY DAMAGE TO THE VIDEO SYSTEM CENTER. IN ADDITION, ALL THE LED DIODES ON THE FRONT PANEL FAILED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. THEN, OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT THE ENDOSCOPE IMAGE WAS NOT DISPLAYED WHEN THE ENDOSCOPE WAS MOVED AFTER THE ENDOSCOPE WAS CONNECTED, DUE TO LOOSE VIDEO CONNECTOR SOCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831001 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170

    Patients

    Seq Age Sex Outcome Treatment
    1