MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-10 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[40325819]
A steris field service technician arrived onsite, inspected the unit, and identified a cut on the unit's door gasket. Water was able to pass through the gasket. It is unknown how the unit sustained the reported damage. The technician replaced the door gasket, tested the unit, and confirmed it to be operating according to specification. The unit was returned to service. Section 1 of the operator manual for the reliance eps states, "to avoid slippery floor conditions, immediately wipe up any spilled liquids or drippage. " no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[40325820]
The user facility reported their reliance endoscope processing system was leaking water. No report of injury or procedural delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00017 |
| MDR Report Key | 5493381 |
| Date Received | 2016-03-10 |
| Date of Report | 2016-03-10 |
| Date of Event | 2016-02-12 |
| Date Mfgr Received | 2016-02-12 |
| Date Added to Maude | 2016-03-10 |
| 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 | ENDOSCOPE PROCESSOR |
| Product Code | NZA |
| Date Received | 2016-03-10 |
| 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 | 2016-03-10 |