BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO ADAPTER

    MDR report key: 14550712 · Received May 31, 2022

    Report

    Report Number
    8010047-2022-09143
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Report Date
    July 14, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNR
    UDI-DI
    04953170023392
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, AND AN INITIAL EVALUATION WAS CONDUCTED BY OLYMPUS; HOWEVER, INVESTIGATION IS ONGOING. DURING THE INITIAL EVALUATION, AS NOTED, THE UNIT HAD UNDERGONE INSUFFICIENT REPROCESSING DUE TO BIOLOGICAL MATERIAL HAVING BEEN FOUND IN THE AIR/WATER LEAKAGE AREA. ADDITIONALLY, PHYSICAL DAMAGE WAS NOTED ON THE SUBJECT DEVICE, AS WELL AS A IMAGING FOCUSING PROBLEM - CONFIRMING THE USER'S REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING THE DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE INVESTIGATION CONFIRMED THE REPORTED IMAGE THAT WAS OUT OF FOCUS. WATER INVASION AND CORROSION WERE NOTED INSIDE THE DEVICE. THE CAUSE OF THE WATER INVASION WAS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED BECAUSE THE LOT NUMBER OF THE SUBJECT DEVICE WAS UNKNOWN. THE INVESTIGATION DID NOT ESTABLISH A ROOT CAUSE FOR THE REPORTED IMAGE PROBLEM. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER ORIGINALLY RETURNED HER OLYMPUS VIDEO ADAPTER DUE TO A FOCUSING ISSUE. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE SUBJECT DEVICE HAD UNDERGONE INSUFFICIENT REPROCESSING AS BIOLOGICAL FOREIGN MATERIAL WAS FOUND IN THE AIR/WATER WAY. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE INSUFFICIENT REPROCESSING FOUND DURING THE DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705240 VIDEO ADAPTER VIDEO ADAPTER KNR OLYMPUS MEDICAL SYSTEMS CORP. A10-T1 UNKNOWN 04953170023392

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown