MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-31 for RELIANCE EPS ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[54292715]
A service technician from steris' distributor inspected the processor and found that the crimp fitting on the inlet hose to the processors filter bank assembly required replacement. The technician further inspected the processor and found that additional hose fittings required replacement. The service technician repaired the processor, 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
[54292716]
The user facility reported that water was leaking from their processor. No report of injury or procedural delays or cancellations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00087 |
| MDR Report Key | 5919203 |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-05-20 |
| Date Mfgr Received | 2016-05-26 |
| Date Added to Maude | 2016-08-31 |
| 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 EPS ENDOSCOPE PROCESSING SYSTEM |
| Generic Name | PROCESSING SYSTEM |
| Product Code | NZA |
| Date Received | 2016-08-31 |
| 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 | 2016-08-31 |