MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-04-14 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[42653540]
A steris service technician arrived at the facility and was told that the personnel noted a burning smell for approximately 30 seconds which they believed came from the reliance eps unit. The steris technician inspected the reliance eps unit and did not identify any visible burning signs of any sort on the unit. The technician ran a test processing cycle and was unable to duplicate the reported event; no burning smell could be noted. As a precaution, the technician replaced the unit's electric coil, hepa filter, and thermo-disc manual reset. A test cycle was performed and the unit was found operational. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[42653541]
The facility reported they detected a burning smell which they believed was coming from the reliance eps. No smoke was observed by facility personnel. No injury, procedural delay or cancellation was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00038 |
| MDR Report Key | 5576366 |
| Report Source | USER FACILITY |
| Date Received | 2016-04-14 |
| Date of Report | 2016-04-14 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-03-18 |
| Date Added to Maude | 2016-04-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 PROCESSING SYSTEM |
| Generic Name | PROCESSING SYSTEM |
| Product Code | NZA |
| Date Received | 2016-04-14 |
| 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 | 2016-04-14 |