MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[71203954]
The user facility stated the unit alarmed a "fault 36" and the cycle failed. The instruments present during the time of the reported event were reprocessed before use. The reliance endoscope processor is equipped with an access panel which includes a troubleshooting chart for the user to review should a fault occur. A user facility employee opened the access panel to look at the fault chart when the employee observed a small puff of smoke after opening the panel. The "fault 36" alarm occurs when a unit is not generating adequate air pressure within the unit. A steris service technician arrived on site, inspected the unit, and identified that the boot pressure transducer connector piece had cracked, causing a small internal water leak. The technician found that water had leaked onto the air compressor in the unit causing it to overheat and fail resulting in the reported "fault 36" and small puff of smoke. The technician repaired the connector piece and air compressor, tested the unit, and confirmed it to be operating according to specification. The unit was manufactured in 2007 and has been in service for over 9 years. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[71203995]
The user facility reported that smoke was emitting from their reliance endoscope processor. No injury, procedure delay, or cancellation was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2017-00024 |
| MDR Report Key | 6432199 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-02-23 |
| Date Added to Maude | 2017-03-24 |
| 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 | PROCESSOR |
| Product Code | NZA |
| Date Received | 2017-03-24 |
| 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 | 2017-03-24 |