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

Device Problem Leak/Splash (1354)

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

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

There were no instruments present during the time of the reported event.A steris service technician arrived onsite to inspect the caviwave unit and found that the y-strainer cracked on the incoming water line subsequently causing the reported event to occur.The technician replaced the y-strainer and associated components, tested the caviwave console cleaner, and found it be operational.The unit was installed at the customer's location in 2011 and is under steris service agreement for maintenance.No additional issues have been reported.

Event Description

The user facility reported event that their caviwave console cleaner was leaking water.No report of injury.

• Brand Name: CAVIWAVE CONSOLE 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: 7603574
• MDR Text Key: 111851973
• Report Number: 3003950207-2018-00003
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• 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