MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-28 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[87860358]
A steris service technician arrived onsite to the inspect the reliance endoscope processor and found that the processor's connection block cracked allowing water to leak behind the unit onto the electric connector creating the reported event. The technician replaced and repaired the appropriate components, tested the reliance endoscope processor, and confirmed it to be operational. The reliance endoscope processing system was manufactured in 2009 and is serviced and maintained by the user facility. No additional issues have been noted.
Patient Sequence No: 1, Text Type: N, H10
[87860359]
The user facility reported a burning odor emitting from their reliance endoscope processor during a test cycle. No instruments were processed during the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2017-00068 |
| MDR Report Key | 6901625 |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-09-28 |
| 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 | ENDOSCOPE PROCESSOR |
| Product Code | NZA |
| Date Received | 2017-09-28 |
| 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 | 2017-09-28 |