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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULTRA CLEAN SYSTEM INC ULTRA CLEAN SYSTEM; CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
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ULTRA CLEAN SYSTEM INC ULTRA CLEAN SYSTEM; CLEANER, ULTRASONIC, MEDICAL INSTRUMENT Back to Search Results
Model Number TRITON 72
Device Problems Obstruction of Flow (2423); Output below Specifications (3004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2020
Event Type  Injury  
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).
 
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Brand Name
ULTRA CLEAN SYSTEM
Type of Device
CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
Manufacturer (Section D)
ULTRA CLEAN SYSTEM INC
oldsmar 34677
MDR Report Key10940093
MDR Text Key219528451
Report NumberMW5098180
Device Sequence Number1
Product Code FLG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTRITON 72
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 Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age100 YR
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