BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA XENON LIGHT SOURCE

    MDR report key: 11016793 · Received December 16, 2020

    Report

    Report Number
    8010047-2020-10431
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 13, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    NWB
    UDI-DI
    04953170275753
    PMA / PMN Number
    K062049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 28-SEP-2020. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OVN FOR EVALUATION. ACCORDING TO THE INSPECTION OF THE DEVICE BY OVN, MANY CABLES INSIDE THE DEVICE HAD BEEN REMOVED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS POSSIBILITY THAT THE REPORTED EVENT WAS CAUSED BY THE DEVICE NOT TURNING ON DUE TO CABLE DISCONNECTION. AND OMSC HAVE CONCLUDED THAT THE CABLE DISCONNECTION MIGHT HAVE BEEN CAUSED BY THE USER OR A THIRD PARTY DISASSEMBLING THE DEVICE, WHICH IS NOT ALLOWED BY THE INSTRUCTION MANUAL. 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 · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING THE PREPARATION FOR USE, THE EXAMINATION LAMP OF THE DEVICE WAS NOT LIT UP. AND OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) (OVN) AND FOUND THAT THE LIGHT SOURCE DID NOT WORK AND THE EXAMINATION LAMP WAS NOT LIT UP. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480745 VISERA XENON LIGHT SOURCE XENON LIGHT SOURCE NWB OLYMPUS MEDICAL SYSTEMS CORP. CLV-S45 04953170275753

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown