MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-07 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[72421765]
No smoke was observed. No instruments were affected as a result of the reported event. A steris service technician arrived on-site, inspected the unit, and identified the air compressor required replacement. The technician found that the air compressor had overheated, causing the reported burning smell. The technician replaced the air compressor, tested the unit, and confirmed it to be operating according to specification. The unit was manufactured in 2009 and is serviced and maintained by the user facility. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[72421766]
The user facility reported their reliance endoscope processing system (eps) was emitting a burning odor. No injury, procedure delay, or cancellation was reported. No evacuations were required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2017-00026 |
| MDR Report Key | 6472349 |
| Date Received | 2017-04-07 |
| Date of Report | 2017-04-07 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-03-09 |
| Date Added to Maude | 2017-04-07 |
| 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 | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, QUEBEC GIC 8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RELIANCE ENDOSCOPE PROCESSING SYSTEM |
| Generic Name | PROCESSOR |
| Product Code | NZA |
| Date Received | 2017-04-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CANADA CORPORATION |
| Manufacturer Address | 490 ARMAND-PARIS QUEBEC, QUEBEC GIC 8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-07 |