MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-08 for CAVIWAVE PRO ULTRASONIC CLEANER manufactured by Steris Corporation - Distribution Center.
[128072100]
A steris service technician arrived onsite to inspect the unit and identified the root cause of the reported event to the small hole in the face of the check valve. The small hole allowed water and lubricant to leak from the unit out onto the floor. The technician replaced the check valve, tested the unit, confirmed it to be operational, and returned it to service. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[128072101]
The user facility reported that water and lubricant leaked from their caviwave pro ultrasonic cleaner. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2018-00008 |
| MDR Report Key | 8053233 |
| Date Received | 2018-11-08 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-11-08 |
| 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 |
| 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 CLEANER |
| Generic Name | CAVIWAVE CLEANER |
| Product Code | FLG |
| Date Received | 2018-11-08 |
| 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 | 2018-11-08 |