BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 12718115 · Received October 29, 2021

    Report

    Report Number
    8010047-2021-13813
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 5, 2021
    Report Date
    December 27, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K111425
    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 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. -THE SCOPE COMMUNICATION ERROR B30 WAS DISPLAYED ON THE MONITOR DUE TO A FAILURE OF THE AP BOARD. THERE WERE NO BURN MARKS OR DAMAGED PARTS ON THE AP BOARD. -THE THREADS ON THE FRONT PANEL WERE DAMAGED AND THE SCREWS COULD NOT BE FIXED WITH THE PROPER TORQUE. -THE FLAT CABLE BETWEEN THE FRONT PANEL AND THE CM BOARD WAS HEAVILY RUSTED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE FOLLOWING INVESTIGATION RESULTS, THE REPORTED EVENT MAY HAVE BEEN CAUSED BY THE AP BOARD FAILURE. THE CAUSE OF THE FAILURE OF THE AP BOARD COULD NOT BE IDENTIFIED. -FROM THE DEVICE EVALUATION RESULTS, IT WAS CONFIRMED THAT THE REPORTED EVENT WAS CAUSED BY A MALFUNCTION OF THE AP BOARD, BUT THERE WAS NO EVIDENCE OF BURNING OR DAMAGE TO THE PARTS ON THE AP BOARD. -OMSC REVIEWED THE MANUFACTURING HISTORY AND CONFIRMED THAT THERE WAS NO ABNORMALITY IN THE MANUFACTURING RECORD. 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.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER BY PHONE THAT DURING THE PREPARATION FOR USE, THE SCOPE COMMUNICATION ERROR B30 WAS DISPLAYED ON THE MONITOR AFTER CONNECTING THE CAMERA HEAD TO THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615961 VISERA ELITE VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown