MAUDE Adverse Event Report: STERIS CORPORATION - DISTRIBUTION CENTER CAVIWAVE PRO ULTRASONIC CONSOLE

Device Problem Leak/Splash (1354)

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

Event Date 12/31/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified the user facility's water pressure was above the recommended specifications for operation.The technician recorded the facility's water pressures over 100 psi.The force of the water pressure allowed for an o-ring on the filter housing to fail causing the reported water leak.Section 2 of the operator manual for the caviwave pro ultrasonic cleaner states, "other facility requirements: [hot, cold, and deionized water]: 38 psi maximum." it was confirmed that upon installation, the water pressure specifications were within the recommended range for operation.The technician replaced the filters and o-ring, tested the unit, and confirmed it to be operating according to specification.The technician advised the user facility to install a pressure regulator to account for fluctuations in water pressure.Since the reported event, the user facility has installed a pressure regulator as recommended by the steris field service technician.

Event Description

The user facility reported their caviwave pro ultrasonic cleaner was leaking water.No report of injury.

• Brand Name: CAVIWAVE PRO ULTRASONIC CONSOLE
• Type of Device: ULTRASONIC CONSOLE
• Manufacturer (Section D): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5398589
• MDR Text Key: 37144230
• Report Number: 3003950207-2016-00001
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2015
• 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 Number: 1