MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-16 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[100537131]
The customer is conducting an investigation as follow-up to an endoscopy procedure that had been completed the day prior. The hospital stated that the patient reported having an unidentified residue or deposit post procedure. We understand the hospital is reviewing all their pre- and post-procedural standard operating procedures, and is asking the instrument/scope manufacturers, as well as the manufacturer of the reprocessing device to perform an evaluation of their equipment in an attempt to identify the root cause of this foreign deposit. A steris service technician arrived onsite to inspect the reliance eps unit. The technician ran two processing cycles which both completed successfully and confirmed the functions of the reliance eps to be operating according to specification. A chemical indicator was present in both test cycles and evidenced passing results. The technician also inspected the chamber and rack assembly and found no issues. While onsite the technician observed the user facility conduct a resitest (used to detect proteins) on each of the scope ports within the reliance eps unit. No residue was detected and the resitest was negative. The technician confirmed that the unit was operating according to specifications. No repairs were made. The reliance eps was returned to service and no additional issues have been reported by the customer. Our investigation concluded that our reliance eps processor is operating according to specification. We do however believe there is an opportunity to provide refresher in-service training to the customer on proper pre-cleaning, processing and inspection of devices. We have scheduled on-site training by our steris account manager and clinical education specialist for february 22, 2018. In the course of supporting the customer's investigation into the reported event, we became aware that the scope used in the patient procedure was an olympus pcf h190 colonoscope. As the oem has not reported under 21 cfr part 803 to fda to date, we have transferred this complaint to the oem for additional investigation by the oem and subsequent reporting under 21 cfr part 803 if deemed necessary.
Patient Sequence No: 1, Text Type: N, H10
[100537132]
The user facility contacted steris requesting functional testing of their reliance endoscope processor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2018-00013 |
| MDR Report Key | 7278138 |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-01-19 |
| Date Mfgr Received | 2018-01-19 |
| Date Added to Maude | 2018-02-16 |
| 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 | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| 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 PROCESSOR |
| Generic Name | PROCESSOR |
| Product Code | NZA |
| Date Received | 2018-02-16 |
| 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 | 2018-02-16 |