BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 9

    MDR report key: 4173121 · Received October 10, 2014

    Report

    Report Number
    2523209-2014-00026
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    CUSTOM ULTRASONICS
    Product Code
    KOG
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO REPORTED INJURIES ASSOCIATED WITH THIS INCIDENT. THE REPORTED SYMPTOM WAS ATTRIBUTED TO A SHORTED DIODE WITHIN THE BRIDGE RECTIFIER, BRG1, ON THE ULTRASONIC GENERATOR (500 W) BOARD, P/N 12008, CAUSING THE FUSE TO OPEN, RENDERING THE BOARD INOPERABLE. THE LOSS OF THE ULTRASONIC GENERATOR DOES NOT, OF AND BY ITSELF, RESULT IN AN ENDOSCOPIC HIGH LEVEL DISINFECTION PROCESS FAILURE THAT DOES NOT RENDER A MICROBIOLOGICALLY SAFE PRODUCT OR PRESENT ANY ADDITIONAL RISKS FOR REUSE GIVEN THE NATURE OF THE PRE-CLEANING LABELING INSTRUCTIONS AND HIGH-LEVEL DISINFECTION. THE BIOMED/FACILITY STAFF WAS PROVIDED A COPY OF TECHNICAL BULLETIN - (B)(4). THE CUSTOMER WAS ALSO INFORMED THAT THIS PROCEDURE SHOULD BE CARRIED OUT EVERY MORNING PRIOR TO THE PROCESSING OF ANY SCOPES. GIVEN THE NATURE OF ENDOSCOPE PRE-PROCESSING AND HIGH-LEVEL DISINFECTION BASED ON SGNA GUIDELINES, EITHER THE PRESENCE OR ABSENCE OF ULTRASONICS SHOULD STILL RESULT IN AN ENDOSCOPE THAT HAS HAD ITS BIOBURDEN REDUCTED TO AN ACCEPTABLE LEVEL. IT IS CONCLUDED THAT THERE IS NO REASONABLE LIKELIHOOD THAT AN ENDOSCOPE PROCESSED IN THE ABSENCE OF THE ULTRASOUND WILL PRESENT ANY ADDITIONAL RISKS.

    Description of Event or Problem · 1

    ULTRASONICS IN BAY 1 OF THE SYSTEM 83 PLUS 9 UNIT DID NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642769 SYSTEM 83 PLUS 9 ENDOSCOPE WASHER-DISINFECTOR KOG CUSTOM ULTRASONICS

    Patients

    Seq Age Sex Outcome Treatment
    1