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

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.

• Brand Name: SYSTEM 83 PLUS9
• Type of Device: ENDOSCOPE 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 Key: 5019219
• MDR Text Key: 24691278
• Report Number: 3007082252-2015-00003
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1