MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-23 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[48019740]
User facility personnel were not placing a container of reliance dry chemistry into the reliance eps prior to processing thus causing the fault 38 to occur. The operator manual states section 7 troubleshooting (pp. 7-17), fault 38: fresh dry chemistry container not detected. A new reliance dry chemistry container was not inserted in the reliance cds prior to cycle start. Cycle is aborted. Start new cycle after ensuring a new reliance dry chemistry container is installed in reliance cds and ensuring latch is closed on reliance cds. If situation reoccurs, call steris. When fault 38 occurred, the user facility operator would acknowledge the alarm. Following the acknowledgement of the alarm, the cycle printout displayed "warning- load not h-l disinfected". A steris service technician inspected the processor and found it to be operating properly; no issues were noted. The reliance eps operated properly by alarming fault 38 as no dry chemistry was placed in the processor for a cycle. The operator manual states (pp. 1-1), "lack of appropriate training could result in injury or equipment damage. " the operator manual states (pp. 1-3), "steris makes no claim of processing efficacy when these processing instructions are not followed. " the operator manual states (pp. 4-24), "installing reliance dry chemistry container-following directions for use in the reliance dry chemistry package insert, prepare and insert container into the processor reliance cds. Once the reliance dry chemistry container is inserted; close and latch reliance cds. " the operator manual states (pp. 4-26), "pre-processing checklist: the following conditions are necessary to achieve successful processing of the endoscopes and accessory types listed in the endoscope quick reference guide. " the user facility requested that steris perform in-service training on the proper use and operation of the reliance eps. The steris account manager is working with the user facility to schedule a date.
Patient Sequence No: 1, Text Type: N, H10
[48019741]
The user facility reported their reliance eps displayed an alarm fault 38 (fresh dry chemistry container not detected). The scope present was subsequently used in a patient procedure. The user facility followed their protocol for patient notification. No adverse affects have been reported. No procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00064 |
| MDR Report Key | 5744634 |
| Report Source | USER FACILITY |
| Date Received | 2016-06-23 |
| Date of Report | 2016-06-23 |
| Date of Event | 2016-04-01 |
| Date Mfgr Received | 2016-05-26 |
| Date Added to Maude | 2016-06-23 |
| 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 | 2016-06-23 |
| 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 | 2016-06-23 |