BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER-2

    MDR report key: 6935783 · Received October 10, 2017

    Report

    Report Number
    2150060-2017-00045
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    October 6, 2017
    Report Date
    October 10, 2017
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    NVE
    UDI-DI
    00677964052491
    PMA / PMN Number
    K871712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDIVATORS CLINICAL EDUCATION SPECIALIST REPORTED THAT THE FACILITY WAS REQUESTING IN-SERVICE TRAINING FOR THEIR CER-2 AUTOMATED ENDOSCOPE REPROCESSORS AFTER THE FACILITY OBSERVED THEY HAD REPROCESSED SCOPES USING A DAMAGED HOOKUP (CLM-110-HU0129). DUE TO THE DAMAGED HOOKUP BEING USED DURING REPROCESSING, THERE IS POTENTIAL THAT SCOPES WERE NOT PROPERLY HIGH LEVEL DISINFECTED PRIOR TO PATIENT PROCEDURES BEING PERFORMED. THE FACILITY IDENTIFIED TWO PATIENTS AT RISK FOR CROSS CONTAMINATION EXPOSURE. THE FACILITY PLANS TO NOTIFY THESE PATIENTS. THE DAMAGED HOOKUP WAS DESTROYED AND REPLACED WITH A NEW HOOKUP. SINCE DISCOVERY OF THIS ISSUE, MEDIVATORS CES PROVIDED IN-SERVICE TRAINING AT THE FACILITY ON 10/05/2017 ON THE PROPER REPROCESSING OF SCOPES USING THEIR CER MACHINES AND HOOKUPS. THE CONDITION OF THE TWO AFFECTED PATIENTS REMAINS UNKNOWN. MEDIVATORS WILL CONTINUE TO MONITOR THIS COMPLAINT IN MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    MEDIVATORS CLINICAL EDUCATION SPECIALIST REPORTED THAT A FACILITY WAS REQUESTING A FULL IN-SERVICE TRAINING FOR THEIR CER-2 AUTOMATED ENDOSCOPE REPROCESSORS AFTER A DAMAGED HOOKUP WAS USED DURING SCOPE REPROCESSING. DUE TO THE DAMAGED HOOKUP, THERE IS POTENTIAL THAT SCOPES WERE NOT PROPERLY HIGH LEVEL DISINFECTED. THE FACILITY HAS IDENTIFIED 2 PATIENTS WHO HAD PROCEDURES PERFORMED WITH SCOPES THAT WERE REPROCESSED WITH THE DAMAGED HOOKUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718142 CER-2 AUTOMATED ENDOSCOPE REPROCESSOR NVE MEDIVATORS, INC. 00677964052491

    Patients

    Seq Age Sex Outcome Treatment
    1 Other