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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - DISTRIBUTION CENTER CAVIWAVE PRO ULTRASONIC CLEANER; CAVIWAVE CLEANER
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STERIS CORPORATION - DISTRIBUTION CENTER CAVIWAVE PRO ULTRASONIC CLEANER; CAVIWAVE CLEANER Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2018
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and identified the root cause of the reported event to the small hole in the face of the check valve.The small hole allowed water and lubricant to leak from the unit out onto the floor.The technician replaced the check valve, tested the unit, confirmed it to be operational, and returned it to service.No additional issues have been reported.
 
Event Description
The user facility reported that water and lubricant leaked from their caviwave pro ultrasonic cleaner.No report of injury.
 
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Brand Name
CAVIWAVE PRO ULTRASONIC CLEANER
Type of Device
CAVIWAVE CLEANER
Manufacturer (Section D)
STERIS CORPORATION - DISTRIBUTION CENTER
6100 heisley rd
mentor OH 44060
Manufacturer (Section G)
STERIS CORPORATION - DISTRIBUTION CENTER
6100 heisley rd
mentor OH 44060
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key8053233
MDR Text Key128072100
Report Number3003950207-2018-00008
Device Sequence Number1
Product Code FLG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/11/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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