MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-02 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[101502232]
All instruments were reprocessed prior to use in procedures. During the time of the reported event, the unit's filtration system was not operating properly which caused the cycle to abort. A steris service technician arrived onsite to inspect the unit and found that one of the unit's electrical components had shorted subsequently causing a burning odor and the filtration system to not operate properly. Additionally, the technician observed a small amount of heat damage around the electrical component. The technician replaced the filtration system which houses the electrical component, ran a test cycle, and confirmed the unit to be operating according to specification. The root cause of the shorted electrical component could not be determined as the damaged component was discarded. The unit was manufactured in 2011 and no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[101502233]
The user facility reported a burning odor emitting from their reliance eps. No report of injury, procedure delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2018-00022 |
| MDR Report Key | 7310101 |
| Date Received | 2018-03-02 |
| Date of Report | 2018-03-02 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-01-31 |
| Date Added to Maude | 2018-03-02 |
| 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 | 2018-03-02 |
| 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 | 2018-03-02 |