MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-06 for CAVIWAVE PRO ULTRASONIC CLEANING SYSTEM manufactured by Steris Corporation - Distribution Center.
[104833117]
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.
Patient Sequence No: 1, Text Type: N, H10
[104833118]
The user facility reported that smoke was emitting from their caviwave pro ultrasonic cleaner. No report of injury, procedure delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2018-00001 |
| MDR Report Key | 7402342 |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-09 |
| Date Mfgr Received | 2018-03-09 |
| Date Added to Maude | 2018-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS CORPORATION - DISTRIBUTION CENTER |
| Manufacturer Street | 6100 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAVIWAVE PRO ULTRASONIC CLEANING SYSTEM |
| Generic Name | CLEANING SYSTEM |
| Product Code | FLG |
| Date Received | 2018-04-06 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - DISTRIBUTION CENTER |
| Manufacturer Address | 6100 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-06 |