BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR

    MDR report key: 5154849 · Received October 15, 2015

    Report

    Report Number
    2084725-2015-00445
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 20, 2015
    Report Date
    September 22, 2015
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K040883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SERVICE HISTORY OF THE EVOTECH¿ ECR SHOWS PREVENTATIVE MAINTENANCE IS UP-TO-DATE. THE UNIT WAS LAST SERVICED ON 07/02/15 WHERE THE BACTERIAL FILTERS WERE REPLACED, AND THE UNIT WAS OPERATING TO SPECIFICATIONS. THE SOURCE OF THE MYCOBACTERIA IS UNKNOWN AT THIS TIME. THERE HAVE BEEN NO REPORTED PATIENT SERIOUS INJURIES OR INFECTIONS. THE PATIENTS CONTINUE TO BE MONITORED BY INFECTIOUS DISEASE AND PULMONARY SPECIALISTS. NO MEDICATIONS TO DATE HAVE BEEN GIVEN TO TREAT THE BACTERIA. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION AND NO PATIENT SERIOUS INJURY OR INFECTION. HOWEVER, SINCE THE SOURCE OF THE BACTERIA IS STILL UNKNOWN AND THE CUSTOMER USED A NON-VALIDATED HIGH LEVEL DISINFECTANT IN THE EVOTECH¿ ECR, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT THIS EVENT DUE TO AN OVERABUNDANCE OF CAUTION. THIS IS SIX OF TWELVE 3500A REPORTS BEING SUBMITTED FOR THIS EVENT. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2015-00440, 2084725-2015-00441, 2084725-2015-00442, 2084725-2015-00443, 2084725-2015-00444, 2084725-2015-00445, 2084725-2015-00446, 2084725-2015-00447, 2084725-2015-00448, 2084725-2015-00449, 2084725-2015-00450, AND 2084725-2015-00451.

    Additional Manufacturer Narrative · 1

    UPON FURTHER FOLLOW-UP WITH THE CUSTOMER, IT WAS DETERMINED THAT METRICIDE¿ OPA WAS NOT USED IN THE EVOTECH¿ ECR AS INITIALLY INDICATED. THE CUSTOMER STATED ONLY CIDEX¿ OPA SOLUTION IS USED IN THEIR EVOTECH¿ ECR AND METRICIDE¿ OPA IS USED ONLY FOR MANUAL CLEANING OF THEIR INSTRUMENTS. (B)(4). METHOD: STERILITY METHOD VERIFICATION. RESULT: NO FAILURE DETECTED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), SERVICE HISTORY RECORD, TRENDING OF THE PRODUCT MALFUNCTION CODE AND SYSTEM RISK ANALYSIS (SRA). THE DHR WAS REVIEWED AND THE UNIT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. NO ISSUES WERE RELATED TO THIS FAILURE MODE. THE SERVICE HISTORY FOR THE PAST SIX MONTHS WAS REVIEWED FROM 4/2/2015 TO 9/29/2015 AND TRENDING WAS NOT EXCEEDED. TRENDING ANALYSIS FOR THE PRODUCT MALFUNCTION CODE OF ''LOAD NOT RECALLED" WAS REVIEWED FROM OCTOBER 2014 THROUGH SEPTEMBER 2015 AND NO SIGNIFICANT TREND WAS OBSERVED. THE SRA WAS REVIEWED FOR THE ISSUE OF "LOAD NOT RECALLED" WITH "QUALITY PROBLEM WITH NO IMPACT TO SAFETY" AND THE RISK WAS DETERMINED TO BE LOW. NO PROBLEM COULD BE FOUND IN REGARDS TO THE FUNCTIONALITY OF THE EVOTECH¿ ECR. THE CUSTOMER'S PROCEDURES FOR SCOPE PROCESSING WERE OBSERVED AND FOUND TO BE FOLLOWED APPROPRIATELY. IT WAS NOTED THE CUSTOMER WAS NOT CHANGING OUT THE MICRON FILTERS IN THEIR WATER FILTRATION SYSTEM AND HAVE BEEN ADVISED TO DO SO ON A REGULAR BASIS. THE ISSUE WILL BE TRACKED AND TRENDED. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TWELVE (12) PATIENTS TESTED POSITIVE FOR ATYPICAL MYCOBACTERIA AFTER UNDERGOING BRONCHOSCOPY PROCEDURES. THE FLEXIBLE BRONCHOSCOPES USED WERE CLEANED AND REPROCESSED IN AN EVOTECH ENDOSCOPIC CLEANER AND REPROCESSOR (ECR). THE FACILITY'S CLEANING METHODS INCLUDED PRE-CLEANING AND SOAKING OF SCOPES WITH PROLYSTICA ENZYMATIC PRESOAK AND CLEANER AND MUNICIPAL WATER THAT INCLUDES A PALL SINGLE-USE WATER FILTER ON THE FAUCET. IT WAS NOTED THAT METRICIDE OPA PLUS CLEANER WAS USED IN THE EVOTECH ECR WHICH IS NOT A VALIDATED HIGH LEVEL DISINFECTANT FOR THE EVOTECH ECR. THE FACILITY CONDUCTED THE FOLLOWING TESTS AND THE RESULTS ARE LISTED BELOW: PATIENT CULTURES WERE TAKEN FROM THE PULMONARY FLUID AND SUBTYPES WERE CONFIRMED BY A DNA PROBE. THE BRONCHOSCOPES USED ON THE PATIENTS WERE FOUND TO BE NEGATIVE FOR THE MYCOBACTERIA. BACTERIAL FILTERS FROM THE EVOTECH⠅CR TESTED POSITIVE FOR THE BACTERIA CONFIRMING THE FILTERS ARE OPERATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684535 EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR EVOTECH EQUIPMENT FEB ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1