BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS WASHER-DISINFECTOR

    MDR report key: 2872353 · Received December 11, 2012

    Report

    Report Number
    2523209-2012-00003
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    September 25, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    KOG
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ULTRASONICS INC. RECEIVED A COPY OF REPORT (B)(6) FROM THE (B)(4). THE REPORT MADE REFERENCE TO "INJURY" AND "REQUIRED INTERVENTION". CUSTOM ULTRASONICS INC. DID FOLLOW UP WITH THE FACILITY TO VERIFY IF ANY INJURY OCCURRED AND WHAT INTERVENTION WAS NECESSARY. THE DIRECTOR OF BIOMED STATED THAT THERE WAS NO INJURY ONLY A POTENTIAL FOR INJURY AND THAT THE INTERVENTION WAS TO REMOVE THE WASHER-DISINFECTOR FROM SERVICE. CUSTOMER ULTRASONICS RECEIVED NOTIFICATION FROM THIS FACILITY THAT LIQUID WAS COMING OUT OF THE DISTAL END OF THE SCOPE, AND NOTICED TWO BULKHEADS WERE BLOCKED. THE BIOMED STAFF AT THE FACILITY TOOK THE UNIT OUT OF SERVICE, REPLACED THE PARTS AND REPROCESSED THE SCOPE THAT HAD THE LIQUID COMING OUT OF THE DISTAL END. THE INVESTIGATION PERFORMED BY CUSTOMER ULTRASONICS INC. REVEALED THAT THE OEM O RINGS OF THE BULKHEAD WERE REPLACED PRIOR TO THE CU TECHNICIAN'S ARRIVAL. THE CU TECHNICIAN REPLACED THE BULKHEADS WITH THE RECOMMENDED PARTS. THE BIOMED TECHNICIAN STATED THAT THERE WAS LINT FOUND INSIDE THE FEMALE BULKHEAD AND SOLENOID VALVE SCREENS. THE CU TECHNICIAN DID REVIEW "PROPER USE GUIDELINES" WITH THE GI STAFF. THERE MAY BE A POTENTIAL LOW RISK OF INFECTION ASSOCIATED WITH THE BREACH. THERE HAS BEEN NO REPORTED INJURIES.

    Description of Event or Problem · 1

    IN REFERENCE TO FACILITY MEDWATCH REPORT (B)(6), CLEAR LIQUID COMING OUT OF A PROCESSED ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 83 PLUS WASHER-DISINFECTOR ENDOSCOPE ACCESSORY KOG CUSTOM ULTRASONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1