MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-20 for CAVIWAVE ULTRA SONIC CLEANER manufactured by Steris Corporation - Distribution Center.
[112090967]
A steris service technician arrived onsite following the reported event and spoke with user facility personnel. User facility personnel stated that they observed a small "flame" and smoke emitting from the unit's drain piping. Immediately prior to the event, the unit successfully completed a cycle and was not in use during the time of the reported event. The steris technician inspected the unit and found that the transducer cable was damaged. The transducer cable provides electrical power from the ultrasonic generator to the transducers which are bonded to the underside of the caviwave cleaner's wash tank. During the last routine preventive maintenance in march 2018, no issues were noted with the transducer cable; the cleaner was found to be operating according to specification. A 3-year review of complaint records indicates this to be an isolated event. Due to the damage sustained when extinguishing the flame, steris is working with the user facility to provide a replacement unit.
Patient Sequence No: 1, Text Type: N, H10
[112090968]
The user facility reported that a small flame was observed from the caviwave ultra sonic cleaner. User facility personnel immediately called the on-duty fire fighter. The on-duty fire fighter quickly extinguished the flame. No injuries were associated with the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003950207-2018-00004 |
| MDR Report Key | 7622742 |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-05-19 |
| Date Mfgr Received | 2018-05-22 |
| Date Added to Maude | 2018-06-20 |
| 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 ULTRA SONIC CLEANER |
| Generic Name | CAVIWAVE CLEANER |
| Product Code | FLG |
| Date Received | 2018-06-20 |
| 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 | 2018-06-20 |