MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-18 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[40855483]
The user facility reported that the thermal safety switch would not reset, some areas of the insulation on the heater box were singed, and the drain tube was partially melted. A steris service technician arrived on site, inspected the unit, and confirmed that the safety switch on the heater box would not reset. The user facility declined steris's offer to service the unit and stated they would perform the proper repairs to return the unit to service. The steris equipment warranty expired on 12/31/2014 and the unit is not under contact for maintenance services. The user facility requested to have a heater box assembly, thermodisk, and transformer shipped for repair. Based on the information provided to steris, this event can most likely be attributed to a defective transformer on the drying heating elements. This malfunction would have created an overheating of the elements resulting in the opening of the thermodisk. The operating manual states on pg 6-1 "warning-personal injury and/or equipment damage hazard: regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment. Contact steris to schedule preventive maintenance. "
Patient Sequence No: 1, Text Type: N, H10
[40855484]
The user facility reported a burning smell was emanating from their reliance endoscope processing system. No injury or procedural delay was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00023 |
| MDR Report Key | 5510521 |
| Date Received | 2016-03-18 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-02-14 |
| Date Mfgr Received | 2016-02-23 |
| Date Added to Maude | 2016-03-18 |
| 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 ENDOSCOPE PROCESSING SYSTEM |
| Generic Name | PROCESSING SYSTEM |
| Product Code | NZA |
| Date Received | 2016-03-18 |
| 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 | 2016-03-18 |