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

Model Number SYSTEM 83 PLUS 9

Device Problem Microbial Contamination of Device (2303)

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

Event Date 02/03/2015

Event Type  malfunction  

Manufacturer Narrative

There were no reported patient injuries associated with this report.On (b)(6) 2015, custom ultrasonics was informed by infection control that trace amounts of (b)(6) were found from samples taken on (b)(6) 2014 from both processing chambers of a machine.A liter sample of water was taken from each of the four processing chambers from the two system 83 plus 9 machines at facility (s/n (b)(4)) and sent to a third party for testing.The samples taken from the system 83 plus 9 machine, s/n (b)(4) were found to be negative, while samples taken from system 83 plus 9 machine, s/n (b)(4)-a were positive for mal.The machines utilize the same water source; however, each machine has a dual water filter assembly installed.No further information available at this time.Investigation is ongoing once more information becomes available a follow up report will be submitted.

Event Description

Trace amounts of (b)(6) were found in samples taken on (b)(6) 2014 from both processing chambers of the system 83 plus 9 washer-disinfector.

• 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: 4987854
• MDR Text Key: 25143476
• Report Number: 3007082252-2015-00002
• 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: Health Professional
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYSTEM 83 PLUS 9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2005
• 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