MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-19 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[24782200]
Investigation of this event is currently in process. A follow up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[24782201]
The user facility reported via mw5042957 multiple failures on their reliance eps causing delays in patient procedures and workflow.
Patient Sequence No: 1, Text Type: D, B5
[30286263]
A steris service technician arrived onsite and confirmed that the user facility has three reliance endoscope processing systems. The technician inspected the units and found that the units were alarming a fault 02. Fault 02 prompts the user to inspect/change the a&b filters cartridges. The technician replaced the filters and collected a water sample. The water samples were sent for analysis and indicated that the user facility has elevated copper levels in their water. The technician communicated the results of the water analysis with the user facility. The user facility stated to the steris technician that their reliance endoscope processing systems are operating to specification and no issues have been noted. The steris account manager made multiple attempts to meet with user facility personnel to discuss the reported event and findings however, the user facility was unresponsive. Therefore, it is unknown if the user facility corrected the issue with their incoming water quality.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2015-00050 |
| MDR Report Key | 5014622 |
| Date Received | 2015-08-19 |
| Date of Report | 2015-08-19 |
| Date of Event | 2015-05-29 |
| Date Mfgr Received | 2015-07-20 |
| Date Added to Maude | 2015-08-19 |
| 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 | 3 |
| Brand Name | RELIANCE ENDOSCOPE PROCESSOR |
| Generic Name | ENDOSCOPE PROCESSOR |
| Product Code | NZA |
| Date Received | 2015-08-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-08-19 |