MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for SYSTEM 1E PROCESSOR manufactured by Steris Canada Corporation.
[136799544]
Prior to the reported event, facility personnel identified a "fill time" error associated with their system 1e processor and removed the unit from service for repair. Forgetting that the unit was out of service, an employee inserted an s40 sterilant cup into the system 1e processor. Moments later, the employee realized that the unit was not in service and removed the full punctured cup of sterilant from the unit without proper ppe. The employee removed the sterilant cup from the unit which resulted in a small amount of sterilant contacting the employee's finger. The operator manual states the proper ppe required when disposing of the s40 sterilant cup, "to dispose of partially filled, leaking, damaged, or expired sterilant containers, put on appropriate personal protective equipment (chemical-resistant gloves, apron, goggles or face shield, and any other protection required by facility procedures). Wear protective attire for the entire procedure. " a steris service technician arrived onsite and inspected the unit. The technician made the appropriate repairs to address the fill time error, completed preventive maintenance activities, ran a test cycle, and returned the unit to service. While onsite, the technician counseled facility personnel on proper use and operation of the system 1e processor and s40 sterilant, specifically, the importance of wearing proper ppe. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[136799585]
The user facility reported that an employee felt a burning sensation on her finger while removing a full s40 sterilant cup from their system 1e processor. The employee rinsed her finger under cold water and as a precaution was sent the emergency room. The employee did not miss any days of work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2019-00008 |
| MDR Report Key | 8311797 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-01-14 |
| Date Added to Maude | 2019-02-06 |
| 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 | SYSTEM 1E PROCESSOR |
| Generic Name | SYSTEM 1E PROCESSOR |
| Product Code | MED |
| Date Received | 2019-02-06 |
| 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 | 2019-02-06 |