BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR

    MDR report key: 5112171 · Received September 29, 2015

    Report

    Report Number
    2084725-2015-00414
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K040883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 3/7/2015 TO 9/3/2015 AND TRENDING WAS NOT EXCEEDED. TRENDING ANALYSIS FOR THE PRODUCT MALFUNCTION CODE OF ''PROCEDURE RELATED" WAS REVIEWED FROM OCTOBER 2014 THROUGH SEPTEMBER 2015 AND THERE WAS NO SIGNIFICANT TREND WAS OBSERVED. THE SRA WAS REVIEWED FOR THE ISSUE OF "PROCEDURE RELATED" AND THE RISK WAS DETERMINED TO BE LOW. THE CLIP WAS REPORTED TO BE LESS THEN 1/4 TO 1/2 INCH IN SIZE BUT SMALL ENOUGH TO PASS FLOW PARAMETERS. THUS, HIGH-LEVEL DISINFECTION WAS ACHIEVED AND THE CYCLE COMPLETED AND MET FUNCTIONALITY. NO INJURIES WERE REPORTED. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR. THE CUSTOMER STATED THEY FOLLOW THE RECOMMENDED BEDSIDE PRE-CLEANING ACCORDING TO THE SCOPE MANUFACTURERS INSTRUCTIONS FOR USE (IFU), BUT THEY DID NOT FOLLOW THE EVOTECH® ECR USER GUIDE WHICH STATES TO CHECK AND REMOVE ALL STENTS/CLIPS IN THE SCOPE PRIOR PLACING INTO THE EVOTECH® ECR. THE USER GUIDE FURTHER STATES, "THESE INSTRUCTIONS, BASED ON THE SGNA GUIDELINES, ARE NOT INTENDED TO REPLACE THE INSTRUCTIONS PROVIDED BY THE MANUFACTURERS OF THE ENDOSCOPES, BUT ARE TO BE USED IN CONJUNCTION WITH THEM." THE CUSTOMER WAS PROVIDED ADDITIONAL TRAINING AND EDUCATION ON PROPER BEDSIDE CLEANING PRIOR TO PLACING IN THE EVOTECH® ECR. IN ADDITION, THE CUSTOMER HAS BEEN SINCE MODIFIED THEIR PRE-CLEANING PROCEDURE TO INCLUDE BRUSHING OF THE SCOPE AND CHECKING FOR STENTS AND CLIPS. THE ISSUE WILL BE TRACKED AND TRENDED. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NI

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A BOSTON SCIENTIFIC CLIP WAS FOUND IN THEIR OLYMPUS ENDOSCOPE AFTER IT WAS REPROCESSED IN AN EVOTECH ENDOSCOPIC CLEANER AND REPROCESSOR (ECR). THE SCOPE WAS USED ON A PATIENT BEFORE THE CLIP WAS DISCOVERED. IT IS UNKNOWN HOW LONG THE CLIP HAD BEEN THERE. THE EVOTECH ECR COMPLETED THE CYCLE. THE HOSPITAL'S PRE-CLEANING STEPS ARE NOT KNOWN AT THIS TIME. THERE IS NO REPORTED PATIENT INJURY OR INFECTION AT THIS TIME. HOWEVER, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED THAT THIS SITUATION COULD PRESENT A POTENTIAL RISK OF INFECTION AND HAS DECIDED TO REPORT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641872 EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR EVOTECH EQUIPMENT FEB ADVANCED STERILIZATION PRODUCTS NA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1