MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for SYSTEM 1E PROCESSOR manufactured by Steris Canada Corporation.
[146932875]
The purpose of the system 1e diagnostic cycle is to verify the proper functioning of the processor. The cycle is initiated differently than a processing cycle. A steris service technician inspected the unit and verified that the system 1e processor was operating properly. Following a test processing cycle, the chemical indicator evidenced passing results. The unit has remained in service since the event and no additional issues have been reported. Steris is not aware of any adverse clinical event associated with this incident and is filing this mdr because the sterility of devices processed in the system 1e cannot be guaranteed unless devices are processed in accordance with steris's instructions for processing and use. Refresher in-service training for the hospital regarding proper use and operation of the system 1e was offered; however, the hospital declined.
Patient Sequence No: 1, Text Type: N, H10
[146932876]
The user facility reported that an employee ran a diagnostic cycle instead of a processing cycle to process a scope in their system 1e processor. When the hospital reported the event to steris, the hospital acknowledged that the system 1e operating instructions were not followed. The facility inquired whether a scope processed in this manner would be sterile as the employee had placed a cup of s40 in the processor prior to initiating the cycle. The hospital was informed by steris that devices cannot be guaranteed as sterile or patient ready unless processed in accordance with steris's instructions for processing and use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2019-00018 |
| MDR Report Key | 8656334 |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-30 |
| 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, 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 | PROCESSOR |
| Product Code | MED |
| Date Received | 2019-05-30 |
| 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, GIC 8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-30 |