MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-04 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[44905831]
A steris service technician inspected the processor and found that wire crimps to the recirculation pump evidenced signs of heat damage. One of the wires on the recirculation pump was not properly crimped causing the wire to overheat and melt the protective sleeve on the wiring. The technician repaired the damaged wiring, ran a test cycle and confirmed the processor to be operating properly.
Patient Sequence No: 1, Text Type: N, H10
[44905832]
The user facility reported that a burning smell was emitting from their reliance eps. No smoke was observed. No report of injury or procedural delays or cancellations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00042 |
| MDR Report Key | 5632047 |
| Date Received | 2016-05-04 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2016-04-11 |
| Date Added to Maude | 2016-05-04 |
| 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 ENDOSCOPE PROCESSING SYSTEM |
| Generic Name | PROCESSING SYSTEM |
| Product Code | NZA |
| Date Received | 2016-05-04 |
| 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 | 2016-05-04 |