MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-10 for CAVIWAVE PRO ULTRASONIC CLEANING SYSTEM manufactured by Steris Corporation - Distribution Center.
[82663650]
A steris service technician arrived onsite to inspect the unit and during inspection observed smoke emitting from the unit. During the technician's visit, user facility personnel disclosed that smoke had emitted prior to his arrival and inspection. User facility personnel stated the instruments present were manually washed prior to use. The technician inspected the unit and found the lid motor, pumps and drain valves to be operating properly. Further inspection found a damaged water solenoid specifically, water intrusion causing a short causing the surrounding plastic housing to overheat and smoke. The cause of the water intrusion is attributed to flushing lumens inside the chamber, specifically the end of the lumens were not connected to an instrument causing them to spray near or directly onto the lid rubber foam seal eventually causing water to push through the seal and down inside the caviwave components. The steris service technician repaired the unit, ran a test cycle and confirmed the unit to be operating properly. The caviwave was returned to service and no additional issues have been reported. The steris service technician performed in-service training instructing user facility personnel to disconnect unutilized flush lumen(s) from the manifold when not in use.
Patient Sequence No: 1, Text Type: N, H10
[82663691]
The user facility reported their caviwave pro ultrasonic cleaning system was not operating properly. No report of injury, procedure delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2017-00005 |
| MDR Report Key | 6785471 |
| Date Received | 2017-08-10 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-13 |
| Date Added to Maude | 2017-08-10 |
| 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 | MS. LYNDSEY SNYDER |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927386 |
| 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 | 2017-08-10 |
| 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 | 2017-08-10 |