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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found the source of the leak to be a small hole in the check valve and a dent in the valve seat.The small hole in the check valve allowed water to leak from the unit and out onto the floor.The technician replaced the check valve including the valve seat, tested 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 were leaking from their caviwave pro ultrasonic cleaner.No report of injury.

• 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 Key: 7975040
• MDR Text Key: 124834972
• Report Number: 3003950207-2018-00006
• 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
• Type of Report: Initial
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• 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 Received: 09/17/2018
• 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 Number: 1