MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-05 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[44905843]
Instruments involved with the failed cycle were appropriately reprocessed by the user facility. The steris operator manual states on pg 1-3 "warning - ineffective process hazard: always verify reliance dry chemistry container is empty after cycle is completed. If undissolved powder is present in container or reliance cds at the end of cycle, load cannot be considered high level disinfected. " a steris service technician arrived on site, inspected the unit, and found that the reliance hld cartridge was not being properly dissolved at the end of a cycle due to the chemical delivery system (cds) operating improperly. Steris r&d personnel reviewed the complaint and determined the most likely cause of this issue was due to a leak coming from either the hld cartridge or the cds lid resulting in a loss of water pressure. This allowed the processing cycle to complete without sufficient pressure to fully dissolve the powders within the reliance hld cartridge. The technician replaced the cds, tested the unit, and confirmed it to be operating according to specification. The unit was installed on (b)(6) 2011 and is not under steris contract for maintenance services. The operator manual describes the recommended proper maintenance of the cds is section 6. 2 on page 6-2 and 6-3. This event can be attributed to improper maintenance of the reliance eps.
Patient Sequence No: 1, Text Type: N, H10
[44905844]
The user facility reported that powders within a reliance hld cartridge did not dissolve properly during reliance eps processing cycles. Procedural delays and cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00044 |
| MDR Report Key | 5633882 |
| Date Received | 2016-05-05 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-03-24 |
| Date Mfgr Received | 2016-04-07 |
| Date Added to Maude | 2016-05-05 |
| 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 | 2016-05-05 |
| 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 | 2016-05-05 |