MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-18 for RELIANCE EPS ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[60761383]
The instruments present during the time of the reported event were reprocessed before use. A steris service technician inspected the processor and found that the air compressor was not functioning properly. The air compressor not operating properly caused the unit to emit the burning odor as reported by user facility personnel. Since the air compressor was not operational, no pressure was created thus resulting in fault 48 as observed by personnel. The technician replaced the air compressor, ran a test cycle and confirmed the processor to be operating properly.
Patient Sequence No: 1, Text Type: N, H10
[60761384]
The user facility reported that their reliance endoscope processor was emitting a burning odor and alarming a "fault 48". No report of injury. No procedure delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00119 |
| MDR Report Key | 6113071 |
| Date Received | 2016-11-18 |
| Date of Report | 2016-11-18 |
| Date of Event | 2016-10-28 |
| Date Mfgr Received | 2016-10-28 |
| Date Added to Maude | 2016-11-18 |
| 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 | 2016-11-18 |
| 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 | 1. Other | 2016-11-18 |