MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[138920652]
A (b)(6) service technician arrived onsite following the reported event to inspect the reliance endoscope processor. The technician spoke with user facility personnel and was informed that contrary to the reported event there was no fire observed, only smoke and a burning smell coming from the chamber. The root cause of the reported event can be attributed to the unit's drying fan. The drying fan failed, causing the heating elements in the unit to overheat and produce the smoke ad burning smell. The technician replaced the drying fan and heating elements, ran several test cycles, and confirmed the unit to be operating according to specification. However, per the customer's request, the unit was de-installed and put into storage. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[138920653]
The user facility reported their reliance endoscope processor started to smoke and caught fire. The department where the unit was located was evacuated due to the burning smell, resulting in procedure delays. Two employees were sent home for the day. No medical treatment was sought or administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2019-00010 |
| MDR Report Key | 8418572 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-02-17 |
| Date Added to Maude | 2019-03-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-03-13 |
| 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 | 2019-03-13 |