MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for CAVIWAVE ULTRASONIC CLEANER manufactured by Steris Corporation - Distribution Center.
[115917314]
There were no instruments present during the time of the reported event. The unit was removed from service following the reported event. A steris service technician arrived onsite to inspect the caviwave unit and found the source of the leak to be the incoming water line y-strainer. The technician made the necessary repairs including replacement of the y-strainer cap, tested the unit, and confirmed the unit to be operating per specification; however, upon further communication with the user facility they have requested to replace the caviwave ultrasonic cleaner with a new cleaner. The new cleaner was installed at the customer's location on (b)(6) 2018. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[115917315]
The user facility reported that their caviwave ultrasonic cleaner was leaking water. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2018-00005 |
| MDR Report Key | 7741038 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-08-01 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-07-05 |
| Date Added to Maude | 2018-08-01 |
| 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 ULTRASONIC CLEANER |
| Generic Name | CAVIWAVE CLEANER |
| Product Code | FLG |
| Date Received | 2018-08-01 |
| 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 | 2018-08-01 |