MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-07-28 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[50650106]
The user facility reported that testing was performed on devices processed in a eps unit; the facility contacted steris in order to obtain information regarding the test results. Instruments used during the testing were not utilized in patient procedures. No injuries or procedural delays or cancellations were reported. The user facility's reliance eps units are under steris service contract and have received routine preventive maintenance. No issues were noted with the reliance eps units during preventive maintenance and the units were found to be operating according to specifications. The reliance eps units are currently in use at the user facility. A steris account manager has made repeated attempts to obtain additional information regarding the testing that was conducted at the user facility however, user facility personnel declined to provide any additional information regarding the nature and purpose of the reported testing, if the facility was following proper operating procedures for the eps unit during the testing, and if the devices which were processed in the eps are validated for use in the unit. Should additional information become available a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[50650107]
The user facility contacted steris with an inquiry regarding their reliance eps unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00073 |
| MDR Report Key | 5829414 |
| Report Source | USER FACILITY |
| Date Received | 2016-07-28 |
| Date of Report | 2016-07-28 |
| Date of Event | 2016-07-01 |
| Date Mfgr Received | 2016-07-01 |
| Date Added to Maude | 2016-07-28 |
| 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 |
| 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 | 2016-07-28 |
| 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 | 2016-07-28 |