BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 12612707 · Received October 12, 2021

    Report

    Report Number
    8010047-2021-13029
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    August 7, 2021
    Report Date
    January 17, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS PLANNED TO BE RETURNED TO OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI) BUT HAS NOT BEEN RETURNED YET. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. FROM THE INFORMATION PROVIDED, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THE FOLLOWING: THE SCOPE COMMUNICATION ERROR B30 OCCURRED DUE TO A FAILURE OF THE LVDS (LOW VOLTAGE DIFFERENTIAL SIGNALING) UNIT. WHEN THE DEVICE WAS CONNECTED TO AN OLYMPUS 190 SERIES ENDOSCOPE, THE ENDOSCOPE IMAGE WAS NOT DISPLAYED DUE TO THE FAILURE OF THE LVDS UNIT. DUST HAD ACCUMULATED INSIDE THE DEVICE. THE POWER SUPPLY UNIT WAS DIRTY. THE LID AND FRONT PANEL WERE SCRATCHED. FROM THE ABOVE, THE REPORTED EVENT MAY HAVE BEEN CAUSED BY THE FAILURE OF THE LVDS UNIT. 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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS EVALUATED AT OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI). OMSI CHECKED THE DEVICE AND DUPLICATED THE REPORTED PHENOMENON. AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. -WHEN CONNECTING AN OLYMPUS 190 SERIES ENDOSCOPE, THE ENDOSCOPE IMAGE WAS NOT DISPLAYED AND THE SCOPE COMMUNICATION ERROR B30 OCCURRED DUE TO A FAILURE OF THE LVDS (LOW VOLTAGE DIFFERENTIAL SIGNALING) UNIT. THESE FAILURE MODES ARE MDR REPORTABLE MALFUNCTIONS. -DUST HAD ACCUMULATED INSIDE THE DEVICE. -THE CONNECTOR ON THE REAR PANEL WAS RUSTED. -THE POWER SWITCH WAS DIRTY. -THE LID AND FRONT PANEL WERE SCRATCHED IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING THE PREPARATION FOR USE, THE SCOPE COMMUNICATION ERROR B30 OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. AN OLYMPUS FIELD SERVICE ENGINEER (FSE) THEN INSPECTED THE DEVICE AND FOUND THAT THE SCOPE COMMUNICATION ERROR B30 OCCURRED. FSE VISITED THE USER FACILITY TO INSPECT THE SUSPECTED DEFECTIVE OLYMPUS LIGHT SOURCE CLV-190 AND CROSS-CHECKED THE CLV-190 WITH THE DEVICE AND FOUND THAT THERE WAS THE ISSUE WITH THE DEVICE. THE SCOPE COMMUNICATION ERROR B30 OCCURRED ONLY WHEN THE DEVICE WAS CONNECTED TO AN OLYMPUS 190 SERIES ENDOSCOPE. THE DEVICE WORKED PROPERLY WHEN THE DEVICE WAS CONNECTED TO ANOTHER SERIES OF ENDOSCOPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517090 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown