MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[100927389]
The unit was installed at the user facility in 2009 and is not under steris contract for maintenance services. A steris service technician arrived on-site, inspected the unit, and found that the drying fan was not operating properly which prevented the proper air flow from the unit's heating element. The technician replaced the drying fan and heating element assembly, tested the unit, and confirmed it to be operating according to specification. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[100927390]
The user facility stated their reliance eps was emitting smoke. No injury, procedure delay, or cancellation was reported. The facility's smoke alarm was not activated and no evacuations were required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2018-00018 |
| MDR Report Key | 7290628 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-01-25 |
| Date Added to Maude | 2018-02-22 |
| 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 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 PROCESSOR |
| Generic Name | PROCESSOR |
| Product Code | NZA |
| Date Received | 2018-02-22 |
| 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 | 2018-02-22 |