MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-03 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[74486342]
A water hose which connects to the reliance endoscope processor unit filter assembly leaked water onto the floor. User facility personnel immediately shut off the unit's water supply and contained the water on the floor around the unit. A steris service technician arrived onsite to inspect the reliance endoscope processing system and found a hole through the outer layer of the braided hot water hose. The technician replaced the braided water hose, ran a test cycle, and found the unit to be operating properly. The unit and braided hose were installed at the user facility june of 2007 and have been in use for approximately 10 years. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[74486343]
The user facility reported their reliance endoscope processor was leaking water. No report of injury, procedure delays or cancellations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2017-00034 |
| MDR Report Key | 6541505 |
| Date Received | 2017-05-03 |
| Date of Report | 2017-05-03 |
| Date of Event | 2017-04-03 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-05-03 |
| 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 PROCESSOR |
| Generic Name | PROCESSOR |
| Product Code | NZA |
| Date Received | 2017-05-03 |
| 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 | 2017-05-03 |