BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 10078317 · Received May 21, 2020

    Report

    Report Number
    8010047-2020-02835
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    May 4, 2020
    Report Date
    September 28, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND DEVICE HISTORY RECORD (DHR) REVIEW. THE DHR FOR THE SUBJECT DEVICE WAS REVIEWED AND IT WAS VERIFIED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS. THE LEGAL MANUFACTURER PERFORMED AN INVESTIGATION. THE LEGAL MANUFACTURER DETERMINED THAT THE EVENT WAS DUE TO USER HANDLING (THE DETERGENT REPLACEMENT INDICATOR WAS ON BECAUSE THE DEVICE WAS TURNED ON WITHOUT REPLACING THE DETERGENT TANK). THE DEVICE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING: "DETERGENT REPLACEMENT INDICATOR: THE LAMP BLINKS WHEN DETERGENT TANK NEEDS TO BE REPLACED. THEREFORE, THE DEVICE HAS TO BE TURNED ON AFTER REPLACED THE DETERGENT TANK.

    Additional Manufacturer Narrative · 1

    THE REPORTED PROBLEM WAS RESOLVED WITH THE ASSISTANCE OF OLYMPUS TECHNICAL SUPPORT VIA THE PHONE. A DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. TO RESOLVE THE LCG LIGHT BLINKING, THE USER COMPLETED A DRAIN AND LOAD LCG CYCLE AGAIN TO RESET THE INDICATOR. IT WAS LEARNED THAT THE END USERS PERFORMED A DRAIN LCG THE PREVIOUS WEEK AND THE LOAD LCG WAS NOT PERFORMED UNTIL THE FOLLOWING WEEK. AFTER PERFORMING THE LOAD LCG AND PRIMING THE SYSTEM, THE LCG LIGHT WENT OUT AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED TO OLYMPUS THAT THE ACECIDE WAS REPLACED BUT THE LCG LIGHT CONTINUED TO BLINK ON THE OER-PRO. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542914 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB OLYMPUS MEDICAL SYSTEMS CORP. OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1