BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM

    MDR report key: 10858016 · Received November 17, 2020

    Report

    Report Number
    8010047-2020-09061
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Report Date
    January 28, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170170461
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER FINAL INVESTIGATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DURING THE EVALUATION STEP OF THE COMPLAINT PROCESS BECAUSE THE PRODUCT WAS NOT RETURNED. IN ADDITION, AN INVESTIGATION WAS PERFORMED BY THE LEGAL MANUFACTURER BASED OFF OF THE INFORMATION PROVIDED. A REVIEW OF THE INSTRUCTION FOR USE (IFU) WAS PERFORMED AND IT WAS CONFIRMED THAT IT GIVES INSTRUCTION FOR PROPER FUNCTIONING OF THE PRODUCT IF THE LAMP BURNS OUT DURING A PROCEDURE. THIS MAY PREVENT THE DISCREPANCIES IDENTIFIED. SPECIFICALLY THE IFU STATES; INSTRUCTION MANUAL (CHAPTER 5 OPERATION) WHEN LAMP BURNS OUT. IF THE LAMP BURNS OUT DURING A PROCEDURE, MOVE THE LAMP SELECTION LEVER TO SELECT THE OTHER LAMP (LAMP B OR A) AND CONTINUE THE OPERATION. REPLACE THE LAMP AFTER COMPLETING THE PROCEDURE FOLLOWING THE INSTRUCTIONS GIVEN IN SECTION 6.2, "LAMP REPLACEMENT". A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION AND ADDITIONAL INFORMATION THAT WAS PROVIDED, THE FOLLOWING IS THE MOST LIKELY CAUSE TO THE REPORTED COMPLAINT. LAMP WAS TURNED OFF DURING THE CASE, AND THE USER TRIED TO SWITCH LAMP WITH LAMP SWITCHING LEVER. HOWEVER, SINCE LAMP SWITCHING LEVER WAS NOT IN THE SPECIFIED POSITION, LAMP DID NOT LIGHT, AND IT IS ASSUMED THAT THE PICTURE BECAME DARK.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE SERVICE CENTER FOR EVALUATION. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE LIGHT SOURCE JIGGLES OUT OF PLACE AND THE IMAGE WAS LOSS. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314755 VIDEO SYSTEM VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-SI 04953170170461

    Patients

    Seq Age Sex Outcome Treatment
    1