BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 8084768 · Received November 19, 2018

    Report

    Report Number
    2951238-2018-00709
    Event Type
    Injury
    Date Received
    November 19, 2018
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    UDI-DI
    04953170310522
    PMA / PMN Number
    K062049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM NWB TO FAJ.

    Additional Manufacturer Narrative · 1

    THE SCOPE HAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. DESPITE SEVERAL FOLLOWUP ATTEMPTS, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE REGARDING THE INFECTION, THE PROCEDURE INVOLVED, THE PATIENT OUTCOME, THE SPECIFIC SCOPE INVOLVED, ITS PRE-PROCEDURE INSPECTION, OR WHETHER THE SCOPE DEVICE IS RETURNING TO OLYMPUS FOR EVALUATION. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS SINCE PROVIDED RETRAINING TO ADDRESS THE REPROCESSING ISSUES THAT WERE A POTENTIAL CONTRIBUTING FACTOR. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A CUSTOMER EDUCATION SESSION ON MANUAL CLEANING AND DISINFECTION, OLYMPUS WAS INFORMED THAT THE USER FACILITY HAD EXPERIENCED A PRIOR INFECTION INCIDENT INVOLVING THIS MODEL SCOPE. THE ACTUAL SCOPE SERIAL NUMBER WAS NOT DISCLOSED. THE INFECTION TYPE, DATE OF PROCEDURE AND PATIENT DETAILS WERE NOT DISCLOSED. IT WAS REPORTED THAT PRIOR TO THE EDUCATION SESSION, THE SCOPE REPROCESSING AT THE USER FACILITY HAD NOT BEEN PERFORMING THE LEAK TEST, WAS NOT COMPLETING PRE-CLEANING, DID NOT HAVE THE APPROPRIATE CLEANING BRUSHES FOR THE ENDOSCOPE CHANNELS, DID NOT TAKE THE IRRIGATION PORT OFF BETWEEN USES, AND DID NOT COMPLETELY IMMERSE THE ENDOSCOPE IN HIGH LEVEL DISINFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926912 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORP. CYF-VHR 04953170310522

    Patients

    Seq Age Sex Outcome Treatment
    1 Other