MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-23 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[26760765]
The facility reported the chemical delivery system (cds) dispense canisters were disintegrating/ eroding. The facility stated the erosion of the canisters produced a chalk-like substance which was unable to pass through all of the water/air channels in some of the scopes processed in the eps unit. Due to the presence of the chalk-like substance in the scopes, the facility reprocessed all scopes and verified that the units were free from chemicals prior to use in patient procedures. A service technician arrived at the user facility, inspected the reliance eps unit and confirmed the customer was using the correct, compatible steris hld/dg detergent with the reliance eps. The technician reviewed cycle printouts from the day and stated no alarms or aborts had occurred. The reliance eps operator manual states, "4. 3 post-processing checklist: reliance dry chemistry container and reliance cds chemical delivery system verified for absence of solid residue. " the technician replaced the dispense canisters, tested the unit for correct operation and returned the unit to service. The dispense canisters were requested for further evaluation; however at this time the customer has stated that the canisters are not available. Following the event, the facility stated their service provider indicated they were aware of the eroding issue within the reliance eps unit, however did not replace the canisters when the issue was observed. The facility's service providers have since been instructed to replace the dispense canisters immediately should disintegration/eroding be observed. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[26760766]
The user facility reported an issue with the chemical delivery system located within the reliance eps unit. No injury or procedural delay or cancellation was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2015-00061 |
| MDR Report Key | 5098802 |
| Date Received | 2015-09-23 |
| Date of Report | 2015-09-23 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-09-02 |
| Date Added to Maude | 2015-09-23 |
| 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 | 0 |
| Brand Name | RELIANCE ENDOSCOPE PROCESSING SYSTEM |
| Generic Name | ENDOSCOPE PROCESSOR |
| Product Code | NZA |
| Date Received | 2015-09-23 |
| 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 | 2015-09-23 |