BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 9

    MDR report key: 4987924 · Received August 10, 2015

    Report

    Report Number
    3007082252-2015-00005
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    February 10, 2015
    Report Date
    February 20, 2015
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON CONFIRMATION FROM THE FACILITY, THERE WERE NO REPORTED INJURIES ASSOCIATED WITH THIS EVENT. THE CUSTOM ULTRASONICS AUTHORIZED SERVICE TECHNICIAN INSTRUCTED THE STAFF ON THE USE OF THE CORRECT ADAPTERS. CUSTOM ULTRASONICS WILL CONDUCT RETRAINING AT THIS FACILITY DURING THE WEEK OF MARCH 16, 2015. INSTRUCTIONAL HANDOUTS WILL ALSO BE SUPPLIED AT THAT TIME. CUSTOM ULTRASONICS IS REPORTING THIS INCIDENT OUT OF AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    CUSTOM ULTRASONICS INC. WOULD LIKE TO CLARIFY THAT THE MAJ-855 ADAPTERS NOTED IN THE INITIAL SUBMISSION ARE SUPPLIED BY (B)(4) AND ARE NOT RECOMMENDED FOR USE IN THE SYSTEM 83 PLUS WASHER- DISINFECTOR. UPON FURTHER INVESTIGATION THE IN-SERVICE TECHNICIAN NOTICED THAT SOME OF THE CUSTOM ULTRASONICS ADAPTERS WERE ALTERED; LENGTHS NOT TO SPEC, INCORRECT END FITTINGS, AND A (B)(4) END FITTING WAS PLACED ON A CUSTOM ULTRASONIC ADAPTER. PRINTER WAS NOT FUNCTIONING AND A REPLACEMENT PRINTER WAS ORDERED, HOWEVER ALL DATA IS SAVED TO THE HARD DRIVE AND MAY BE RETRIEVED AND LATER PRINTED. THE IN- SERVICE TECHNICIAN CONDUCTED RE-TRAINING ON THE CORRECT USE OF THE SYSTEM 83 PLUS AND CORRECT USAGE OF ADAPTERS. THE SYSTEM 83 PLUS WAS FUNCTIONING AS INTENDED. THE IN- SERVICE TECHNICIAN PROVIDED PART NUMBERS AND PRICE LIST TO THE FACILITY SO THAT THEY MAY ORDER THE CORRECT CUSTOM ULTRASONICS ADAPTERS. THE (AST) AUTHORIZED SERVICE TECHNICIAN AGREED TO RETURN TO THE FACILITY TO VERIFY THAT THE CORRECT PARTS ARE BEING USED.

    Description of Event or Problem · 1

    DURING A SITE VISIT ON (B)(4) 2015, A CUSTOM ULTRASONICS AUTHORIZED SERVICE TECHNICIAN REPORTED THAT THE STAFF AT THIS FACILITY WAS USING AN INCORRECT ADAPTER (MAJ-855) TO REPROCESS ENDOSCOPES. THE INCORRECT ADAPTER WAS USED TO REPROCESS UPPER AND LOWER GI SCOPES AS WELL AS THE TJF-160 ERCP ENDOSCOPES. IT WAS NOTED THAT THE ERCP ENDOSCOPES ALONG WITH THE UPPER AND LOWER GI ENDOSCOPES MAY NOT HAVE BEEN REPROCESSED PROPERLY. CUSTOM ULTRASONICS WAS MADE AWARE OF THIS INCIDENT ON (B)(4) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522898 SYSTEM 83 PLUS 9 ENDOSCOPE WASHER-DISINFECTOR FEB CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1