BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 11796300 · Received May 10, 2021

    Report

    Report Number
    8010047-2021-06075
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 29, 2021
    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

    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 MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI) FOR EVALUATION. OMSI INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: -THE SCOPE COMMUNICATION ERROR B30 WAS REPRODUCED DUE TO A FAILURE OF THE LOW VOLTAGE DIFFERENTIAL SIGNALING OF THE PRINTED CIRCUIT BOARD. THERE WERE NO BURN MARKS OR DAMAGED COMPONENTS ON THIS PRINTED CIRCUIT BOARD. -THE FRONT PANEL WAS CRACKED AND THE SCREWS COULD NOT BE FIXED WITH THE PROPER TORQUE. -DUST HAD ACCUMULATED INSIDE THE DEVICE. -THERE WERE BUMPS AND SCRATCHES ON THE FRONT PANEL. -THE POWER SWITCH WAS SCRATCHED AND DIRTY. -THE LID AND CHASSIS WERE SCRATCHED. -THE REAR PANEL WAS RUSTED AND CORRODED. OMSC DETERMINED THAT THE REPORTED SCOPE COMMUNICATION ERROR B30 WAS CAUSED BY DEGRADATION. BASED ON THE DEVICE INSPECTION RESULT PROVIDED BY OMSI, OMSC CONFIRMED THAT THE PRINTED CIRCUIT BOARD WAS DEFECTIVE. IN ADDITION, MORE THAN NINE YEARS HAVE PASSED SINCE THE DEVICE WAS MANUFACTURED. THEREFORE, THE SCOPE COMMUNICATION ERROR B30 MAY HAVE OCCURRED DUE TO THE DETERIORATION OF THE PRINTED CIRCUIT BOARD DUE TO REPEATED USE FOR A LONG PERIOD OF TIME. 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 IS PLANNED TO BE RETURNED TO OLYMPUS MEDICAL SYSTEMS (B)(4) PRIVATE LIMITED (B)(4) FOR EVALUATION, BUT HAS NOT YET BEEN RETURNED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, 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 SCOPE COMMUNICATION ERROR B30 OCCURRED WHEN CONNECTING THE OLYMPUS 190 SERIES ENDOSCOPES. ERROR CODE B30 MEANS THAT THE VIDEO SYSTEM CENTER CANNOT COMMUNICATE WITH THE ENDOSCOPE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693816 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1