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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS9 ENDOSCOPE WASHER-DISINFECTOR

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CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS9 ENDOSCOPE WASHER-DISINFECTOR Back to Search Results
Device Problems Device Reprocessing Problem (1091); Restricted Flow rate (1248)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2015
Event Type  Malfunction  
Manufacturer Narrative

Upon checking with the facility , there are no reported injuries associated with this report. The authorized service representative informed the facility that they can no longer process endoscopes using the visually dirty inline adapter disc filters which had significantly restricted the flow. The service technician reviewed the proper reprocessing instructions with the staff. He reiterated the labeling instruction to check for flow through the adapters before each cycle. Custom ultrasonics will conduct training for the staff at this facility on march 16, 2015. Instructional handout will be supplied to the staff during this training session. Custom ultrasonics inc. Is reporting this incident out of an abundance of caution.

 
Event Description

During a service visit to ths facility the technician noticed that the disk filters used to reprocess endoscopes had restricted flow. It was noted that the ercp scopes along with upper and lower gi endoscopes may not have been reprocessed properly.

 
Manufacturer Narrative

Upon further investigation it was noted that the facility was not using the custom ultrasonics' recommended oem parts (inline adapter disk filter replacements) since june 2013. The facility did order the correct inline disk filters from custom ultrasonics inc. On march 13, 2015. On march 16, 2015 the custom ultrasonics in-service technician noticed that the facility was using the adapters without the inline disk filters. The (ast) authorized service technician did confirm that the inline disk filters were delivered to the facility but were being processed into inventory at the time of this visit. During this visit the (ast) technician did supply a few disk filters for immediate use. The (ast) technician also noticed that the staff was reprocessing a olympus adapter maj-855 ((b)(4)) not recommended for use in the system 83 plus washer disinfector. The staff also had the correct olympus adapter mh 974 ((b)(4)) hooked up to the correct fitting on the scope, but incorrectly connected to the standard pressure port and not the correct high pressure port of the system 83 plus washer-disinfector. Custom ultrasonics's in-service technician did re-train the staff on the correct use of the system 83 plus , and the correct usage of adapters. The in- service technician confirmed the system 83 plus worked as intended.

 
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Brand NameSYSTEM 83 PLUS9
Type of DeviceENDOSCOPE WASHER-DISINFECTOR
Manufacturer (Section D)
CUSTOM ULTRASONICS INC.
144 railroad drive
ivyland PA 18974
Manufacturer Contact
elizabeth lazaro
144 railroad drive
ivyland, PA 18974
2153641477
MDR Report Key5019219
MDR Text Key24691278
Report Number3007082252-2015-00003
Device Sequence Number1
Product Code FEB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK983017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/09/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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