MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-14 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[77727614]
A steris service technician arrived onsite to inspect the processor and found the condenser water inlet valve was sticking in the open position. When the valve was de-energized, it caused the condenser to overfill resulting in the chamber water leak. The technician replaced the valve, ran a test cycle and confirmed the processor to be operating properly. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[77727615]
The user facility reported the water was leaking from their reliance eps. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2017-00045 |
| MDR Report Key | 6641525 |
| Date Received | 2017-06-14 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-19 |
| Date Added to Maude | 2017-06-14 |
| 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. LYNDSEY SNYDER |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927386 |
| 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 | 2017-06-14 |
| 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 | 2017-06-14 |