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

Device Problem Smoking (1585)

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

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

All instruments present were manually washed prior to terminal cleaning.A steris service technician arrived onsite to inspect the unit.The technician initiated a test cycle and was able to recreate the reported event.The technician inspected the unit and found that the water solenoid valve was damaged.The steris service technician replaced the solenoid valve, ran a test cycle and confirmed the unit to be operating properly.The caviwave was returned to service.A review of complaint records from the past five years indicate this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that smoke was emitting from their caviwave pro ultrasonic cleaner.No report of injury, procedure delay or cancellation.

• Brand Name: CAVIWAVE PRO ULTRASONIC CLEANING SYSTEM
• Type of Device: CLEANING SYSTEM
• 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: 7402342
• MDR Text Key: 104833117
• Report Number: 3003950207-2018-00001
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• 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: 03/09/2018
• 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