MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-26 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[25014451]
Steris monitors relevant websites and social media sources per our social media policy to identify potential complaints. Through this process, steris identified an anonymous post reporting that their reliance endoscope processor was not operating properly. Steris responded and provided contact information including a phone number however; steris has not received a response. Based on the information provided in the anonymous post this event appears to meet our reporting criteria for medical devices. A follow up report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[25014452]
The complainant reported that their reliance endoscope processor was not operating properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2015-00054 |
| MDR Report Key | 5032610 |
| Date Received | 2015-08-26 |
| Date of Report | 2015-08-26 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2015-07-28 |
| Date Added to Maude | 2015-08-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 PROCESSOR |
| Generic Name | ENDOSCOPE PROCESSOR |
| Product Code | NZA |
| Date Received | 2015-08-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2015-08-26 |