BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 11052971 · Received December 21, 2020

    Report

    Report Number
    8010047-2020-10794
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 26, 2020
    Report Date
    February 5, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    PMA / PMN Number
    K111756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BUT WAS RETURNED TO OLYMPUS CHINA (OCSM). THERE WAS NO IRREGULARITY FOUND ON THE DEVICE. OCSM FOUND THAT THE ARGON KNIFE THAT THE CUSTOMER USED WITH THE SUBJECT DEVICE DISRUPTED THE IMAGE SIGNAL ON THE DEVICE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THERE IS NO SERVICE RECORD FOR THE DEVICE. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THERE IS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO AN ELECTROMAGNETIC INTERFERENCE WITH THE ARGON KNIFE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. 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

    DURING GASTROSCOPY, THE USER FOUND THAT THE ENDOSCOPIC IMAGE BECAME BLUE. THE USER CONTINUED TO USE THE DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509619 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FDF OLYMPUS MEDICAL SYSTEMS CORP. CV-V1

    Patients

    Seq Age Sex Outcome Treatment
    1