MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for RELIANCE EPS ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[59860453]
A steris service technician arrived on site, inspected the unit, and identified the residue within the cds containers. The technician found that the detergent injection lines were not correctly calibrated within the cds causing the reported residue. The technician re-calibrated the detergent injection lines, tested the unit, and confirmed it to be operating according to specification. The unit is not under steris contract for preventative maintenance services. The technician identified the cds calibration issue to be caused from improper maintenance of the reliance eps unit. The steris service technician will work with the facility to ensure calibration maintenance activities are understood and implemented. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[59860454]
The user facility reported undissolved detergent residue left in their chemical delivery system (cds) containers after completed processing cycles. Procedure cancellations were reported as a result of having to reprocess instruments when residue was observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2016-00113 |
| MDR Report Key | 6089920 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-10-11 |
| Date Mfgr Received | 2016-10-11 |
| Date Added to Maude | 2016-11-09 |
| 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 EPS ENDOSCOPE PROCESSING SYSTEM |
| Generic Name | PROCESSING SYSTEM |
| Product Code | NZA |
| Date Received | 2016-11-09 |
| 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 | 1. Other | 2016-11-09 |