MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for SYSTEM 1 EXPRESS manufactured by Steris Canada Corporation.
[133894105]
The user facility's biomed department inspected the system 1 express after the reported event occurred and found that the aspirator probe was cracked, causing a very small amount of sterilant to remain in the cup after the completed cycle. The system 1 express operator manual (pg 1-1) states: "warning: always verify that the sterilant container is empty at the completion of the cycle. " the cycle subject of the reported event completed successfully, and the ci passed. The biomed department replaced the aspirator probe, ran a test cycle, and confirmed the sterilizer to be operating according to specification and returned the unit to service. A steris service technician arrived onsite after the repairs were made. The technician found the unit to be operating according to specification. While onsite the technician was informed by user facility personnel that the employee subject of the reported event was not wearing proper ppe specifically gloves, while disposing the sterilant cup. The system 1 express operator manual (pg 1-3) states: "caution: appropriate personal protective equipment (ppe) is required when handling or disposing of partially filled, leaking, damaged, or expired 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. " the technician was unable to determine the root cause of the cracked aspirator probe however, this is likely attributed to excess force or other misuse by user facility personnel. A steris account manager will offer in-service training on the proper use and operation of the system 1 express specifically, wearing proper ppe, properly disposing of s40 sterilant cups, and properly handling the aspirator probe. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[133894106]
The user facility reported that an employee obtained a burn while removing a partially filled s40 sterilant cup from their system 1 express. No medical treatment was sought or administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2019-00004 |
| MDR Report Key | 8258577 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-12-21 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2019-01-17 |
| 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 1 EXPRESS |
| Generic Name | SYSTEM 1 EXPRESS |
| Product Code | MED |
| Date Received | 2019-01-17 |
| 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 | 2019-01-17 |