MAUDE Adverse Event Report: CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 9; ENDOSCOPE WASHER- DISINFECTOR

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2015

Event Type  malfunction  

Manufacturer Narrative

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 (b)(6) 2015.Instructional handouts will also be supplied at that time.Custom ultrasonics is reporting this incident out of an abundance of caution.

Event Description

During a site visit on (b)(6) 2015 a custom ultrasonics authorized service technician reported that the staff at this facility was using an incorrect adapter (b)(4) to reprocess endoscopes.The incorrect adapter was used to reprocess upper and lower gi endoscopes as well as the tjf-160 ercp endoscopes.It was noted that the echoendoscopes along with the upper and lower gi endoscopes may not have been reprocessed properly.Custom ultrasonics was made aware of this incident on (b)(6) 2015.

Manufacturer Narrative

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 use 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.

• Brand Name: SYSTEM 83 PLUS 9
• 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: 4987919
• MDR Text Key: 24695039
• Report Number: 3007082252-2015-00004
• 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,user f
• Reporter Occupation: Nurse
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• 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: 04/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2003
• 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