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

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/11/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The facility stated that water was backing up within the lubricant bottle.No water was reported outside of the bottle.A steris service technician arrived on site, inspected the unit and identified that water pressure was above the specification for the unit causing the reported event.The technician informed the customer that incoming water exceeded steris water pressure specification for the caviwave pro ultrasonic unit.The unit was removed from service until a pressure regulator can be installed by the user facility's maintenance department.The unit is not under steris contract for maintenance services and all service is performed by the user facility.No additional issues have been reported with the unit.

Event Description

The user facility reported water was backing up in their caviwave pro ultrasonic.No injury, procedural delay, or cancellation was reported.

• Brand Name: CAVIWAVE PRO ULTRASONIC
• Type of Device: ULTRASONIC CLEANER
• 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: 5651081
• MDR Text Key: 45227394
• Report Number: 3003950207-2016-00005
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• 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: 04/12/2016
• 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