BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOTECH ECR 208V

    MDR report key: 11620164 · Received April 6, 2021

    Report

    Report Number
    2084725-2021-00090
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 20, 2021
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    UDI-DI
    10705037030958
    PMA / PMN Number
    K040883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING ANALYSIS OF THE LOAD NOT RECALLED ISSUE, AND SYSTEM RISK ANALYSIS (SRA). THE DHR WAS REVIEWED AND NO ISSUES RELATING THE FAILURE MODE WERE NOTED. THE INVOLVED UNIT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. TRENDING ANALYSIS OF THE LOAD NOT RECALLED ISSUE FOR THE EVOTECH¿ ECR UNIT WAS REVIEWED FOR THE PRIOR SIX MONTHS FROM OPEN DATE AND NO SIGNIFICANT TREND WAS OBSERVED. THE SRA SHOWS THE RISK FOR EXPOSURE TO BIOHAZARDOUS, PATHOGENIC OR INFECTIOUS MATERIAL TO BE "LOW." THE ISSUE HAS BEEN ATTRIBUTED TO USER ERROR AS THE LOAD FROM THE CANCELLED CYCLE WAS RELEASED FOR USE ON PATIENTS PRIOR TO REPROCESSING. A CUSTOMER LETTER WAS SENT INSTRUCTING THE CUSTOMER TO REVIEW THE USER¿S GUIDE WHICH STATES THAT LOADS FROM CANCELLED CYCLES SHOULD BE REPROCESSED. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. ASP COMPLAINT REF #: (B)(4).

    Additional Manufacturer Narrative · 1

    APPROPRIATE TERM/CODE NOT AVAILABLE- LOAD NOT RECALLED. ASP COMPLAINT REF #: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A CYCLE CANCELLATION OF AN A.10.3 OVERFLOW OR SYSTEM LEAK WITH THEIR EVOTECH¿ ECR AND THE CANCELLED CYCLE WAS RELEASED FOR USE ON PATIENTS PRIOR TO REPROCESSING. THERE IS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION HIGH LEVEL DISINFECTION CANNOT BE ASSURED. THEREFORE, ASP HAS DECIDED TO REPORT ALL INCIDENTS OF LOADS THAT ARE RELEASED FROM CANCELLED CYCLES PRIOR TO REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514951 EVOTECH ECR 208V EVOTECH¿ EQUIPMENT FEB ADVANCED STERILIZATION PRODUCTS 50004 N/A 10705037030958

    Patients

    Seq Age Sex Outcome Treatment
    1