MAUDE Adverse Event Report: ULTRA CLEAN SYSTEMS, INC. ULTRA CLEAN SYSTEM; CLEANER, ULTRASONIC, MEDICAL INSTRUMENT

Model Number TRITON72

Device Problems Failure of Device to Self-Test (2937); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2020

Event Type  malfunction  

Event Description

Ultra clean triton 72 does not pass efficacy tests when sanizyme enzymatic detergent is used and dosed at 1 ounce per gallon.Efficacy test and active enzyme test not passing with steris prolystica hp enzymatic detergent and check valve on detergent lines were plugged with debris.Once check valves were replaced, efficacy tests were still not passing in all levels, however active enzyme test strip passed.Sonochecks do not pass in all levels consistently.Based on the efficacy tests and sonocheck device, this sonic machines design doesn't have enough sonication power to reach every level when all lumen baskets are tested together.Fda safety report id# (b)(4).

• Brand Name: ULTRA CLEAN SYSTEM
• Type of Device: CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
• Manufacturer (Section D): ULTRA CLEAN SYSTEMS, INC.; oldsmar FL 34677
• MDR Report Key: 10828979
• MDR Text Key: 216151757
• Report Number: MW5097780
• Device Sequence Number: 1
• Product Code: FLG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRITON72
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1