MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-27 for RELIANCE EPS ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[5526871]
The user facility reported that they are not pre-cleaning their scopes before being processed in their reliance eps.
Patient Sequence No: 1, Text Type: D, B5
[12960003]
Steris offered in-service training on the importance of pre-cleaning instruments before processing and the proper use and operation of the reliance eps as documented in the operator manual. The reliance eps operator manual states, (pp. 4-3), "ensure all items have been manually cleaned, leak tested and prepared for immersion before placing them in the endoscope processing support. " a recommendation has been made to the user facility to manually brush all endoscopic instruments prior to sterilization; not only clips which are visibly soiled. Investigation of this event is currently in process. A follow up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[24374937]
Steris offered in-service training on the proper pre-cleaning procedures. The user facility accepted the offer. A recommendation has been made to the user facility to manually brush all endoscopes prior to processing; not only clips which are visibly soiled.
Patient Sequence No: 1, Text Type: N, H10
[24374938]
No adverse affects have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2015-00025 |
| MDR Report Key | 4555000 |
| Report Source | 06 |
| Date Received | 2015-02-27 |
| Date of Report | 2015-02-27 |
| Date of Event | 2015-01-12 |
| Date Mfgr Received | 2015-01-28 |
| Date Added to Maude | 2015-02-28 |
| 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 | 0 |
| Event Location | 0 |
| 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 GIC8A3 |
| 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 EPS ENDOSCOPE PROCESSING SYSTEM |
| Generic Name | PROCESSING SYSTEM |
| Product Code | NZA |
| Date Received | 2015-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 GIC8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-27 |