MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for CAVIWAVE PRO ULTRASONIC manufactured by Steris Corporation - Distribution Center.
[45227394]
The facility stated that water was backing up within the lubricant bottle. No water was reported outside of the bottle. A steris service technician arrived on site, inspected the unit and identified that water pressure was above the specification for the unit causing the reported event. The technician informed the customer that incoming water exceeded steris water pressure specification for the caviwave pro ultrasonic unit. The unit was removed from service until a pressure regulator can be installed by the user facility's maintenance department. The unit is not under steris contract for maintenance services and all service is performed by the user facility. No additional issues have been reported with the unit.
Patient Sequence No: 1, Text Type: N, H10
[45227395]
The user facility reported water was backing up in their caviwave pro ultrasonic. No injury, procedural delay, or cancellation was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2016-00005 |
| MDR Report Key | 5651081 |
| Date Received | 2016-05-12 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2016-04-12 |
| Date Added to Maude | 2016-05-12 |
| 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. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAVIWAVE PRO ULTRASONIC |
| Generic Name | ULTRASONIC CLEANER |
| Product Code | FLG |
| Date Received | 2016-05-12 |
| 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 | 2016-05-12 |