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

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

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

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

The user facility initially reported that a burning smell and small fire were emitting from the caviwave cleaner.No instruments were present during the time of the reported event.A steris service technician arrived onsite to inspect the unit.Contrary to the reported event, the technician found no evidence of fire damage inside the unit.The technician inspected the unit's electrical components and wiring and found no evidence of smoke or fire.The technician further inspected the unit's generator and found no blown fuses.Prior to the steris service technician's arrival, the user facility's biomedical technician inspected the unit and found that one of the contactors required replacement.The steris technician was able to inspect the contactor and observed a brown discoloration.The cause of the discoloration is attributed to an electrical short condition due to loose wiring at a contactor terminal.The steris service technician replaced the contactor, ran a test cycle and returned the unit to service.No additional issues have been reported.The caviwave ultrasonic cleaner was installed in 2013 and is serviced and maintained by the user facility's 3rd party maintenance provider.The cause of the loose wiring is attributed to lack of preventive maintenance.The steris service technician found five contactor terminal screws required a half turn before they were found to be tight.The preventive maintenance guide states (2x/year), "verify all wire terminal ends at all terminals, terminal strips, relays, contactors, plc and connections are correctly installed, secure, and properly torqued.Ensure no wires show any signs of overheating or discoloration." a steris district service manager (dsm) stated the user facility's 3rd party maintenance provider has purchased the maintenance manuals and have conducted their own biomedical training on the caviwave cleaners.

Event Description

The user facility reported that a burning smell was emitting from their caviwave 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: 6918432
• MDR Text Key: 89936294
• Report Number: 3003950207-2017-00007
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• 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: 09/07/2017
• 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