MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-15 for RELIANCE ENDOSCOPE PROCESSING SYSTEM manufactured by Steris Canada Corporation.
[43444194]
The facility reported the employee's face appeared red and she appeared disoriented and confused while working with the eps unit. A steris service technician arrived at the facility, inspected the unit, and found the unit was experiencing low boot pressure alarms; which caused the cycles to abort. The cause of the boot pressure alarms could not be determined through the technician's inspection. The technician replaced the unit's control handle boot, ran a test cycle, and confirmed the unit was operating according to specification. It is unclear how the employee could have been exposed to any of the chemicals used with the eps. The operator manual (1-1) states, "in an emergency, stop cycle by pressing stop touch pad twice to abort cycle. Wait for processor to complete abort sequence. Wear appropriate personal protective equipment (ppe) when reaching into chamber. " in addition, (1-2) states, "before opening processor door manually, wear appropriate personal protective equipment (ppe). Allow processor to cool down. Avoid inhaling fumes from chamber and contact with any remaining solution. " an individual from steris service engineering will travel to the user facility's account for further evaluation and trouble shooting on the unit. In addition, a formal in-service training will be provided for the user facility staff. The investigation of this event is currently in process. A follow-up report will be submitted once additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[43444195]
The facility reported an employee exhibited signs of irritation while working with the reliance eps. The employee was escorted to the employee health department and resumed normal work duties the following week.
Patient Sequence No: 1, Text Type: D, B5
[47418596]
On april 21, 2016, an individual from steris service engineering arrived at the user facility's account for further evaluation of the reliance eps unit. The inspection did not reveal any issues with the reliance eps unit that would have resulted in the irritation reported by the customer. The unit is operational and safe for use. In-service training was scheduled with the customer on (b)(6) 2016, however the customer cancelled the in-service and has not rescheduled with steris. No further issues have been reported by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2016-00040 |
| MDR Report Key | 5582593 |
| Date Received | 2016-04-15 |
| Date of Report | 2016-04-15 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-03-18 |
| Date Added to Maude | 2016-04-15 |
| 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 | 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 | 3 |
| Brand Name | RELIANCE ENDOSCOPE PROCESSING SYSTEM |
| Generic Name | PROCESSING SYSTEM |
| Product Code | NZA |
| Date Received | 2016-04-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-04-15 |