MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for SYSTEM 1E PROCESSOR manufactured by Steris Canada Corporation.
[131384605]
A steris service technician arrived onsite following the reported event to inspect the system 1e processor. The technician inspected the system 1e processor, ran several test cycles, and found the unit to be operating according to specification; no repairs were required. User facility personnel confirmed the chemical indicator present in the cycle subject of the event evidenced passing results. While onsite, the technician was informed that the employee was not wearing proper ppe and spilled the sterilant on their arm while disposing the s40 sterilant cup. The employee did not follow the proper steps for disposing s40 sterilant. The system 1e operator manual (1-1) states, "warnings: always verify that the sterilant container is empty at the completion of the cycle". The operator manual (1-3) further states, "cautions: appropriate personal protective equipment is required when handling containers of s40 sterilant concentrate. Minimally, ppe should consist of chemical resistant gloves, apron, goggles or face shield, and any other protection required by facility procedures". A steris account manager performed in-service training on the proper use and operation of the system 1e processor, specifically on reprocessing the load if the sterilant container is not empty, handling the sterilant cup, and wearing proper ppe. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[131384606]
The user facility reported that an employee obtained a burn while disposing of s40 sterilant while operating their system 1e processor. The employee sought medical treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2018-00092 |
| MDR Report Key | 8180902 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-19 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-12-19 |
| 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 | 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 | 2018-12-19 |
| 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 | 2018-12-19 |