MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-14 for CAVIWAVE CONSOLE CLEANER manufactured by Steris Corporation - Distribution Center.
[111851973]
There were no instruments present during the time of the reported event. A steris service technician arrived onsite to inspect the caviwave unit and found that the y-strainer cracked on the incoming water line subsequently causing the reported event to occur. The technician replaced the y-strainer and associated components, tested the caviwave console cleaner, and found it be operational. The unit was installed at the customer's location in 2011 and is under steris service agreement for maintenance. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[111851974]
The user facility reported event that their caviwave console cleaner was leaking water. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2018-00003 |
| MDR Report Key | 7603574 |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-05-16 |
| Date Mfgr Received | 2018-05-16 |
| Date Added to Maude | 2018-06-14 |
| 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 CONSOLE CLEANER |
| Generic Name | CAVIWAVE CLEANER |
| Product Code | FLG |
| Date Received | 2018-06-14 |
| 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 | 2018-06-14 |