MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-12-14 for 3017 ETO STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[19228238]
The user facility reported that when operators removed the ethylene oxide canisters after the sterilizer cycles aborted due to "no gas" alarms, liquid remained in the canisters. Two employees went to the emergency room for ethylene oxide exposure assessment, however no treatment was administered. The employees returned to work and are fine with no sustaining injuries.
Patient Sequence No: 1, Text Type: D, B5
[19381696]
A steris service technician inspected the sterilizer and found that the puncture pin was broken. He replaced the puncture cylinder and pin puncture. The sterilizer was returned to service; no further issues have been reported. The cause of the sterilizer alarms was due to improper installation of the ethylene oxide canisters. The operator manual states (pp. 6-4), "the eo cartridge is to be installed into the sterilizer chamber recess located inside the chamber at the front left side". The operator manual further states, "ensure the cartridge is fully seated. Failure to seat the cartridge completely may cause an incomplete cartridge puncture". The canisters were not properly aligned when inserted, causing an incomplete puncture and also the puncture pin to break. The sterilizer is under steris maintenance contract and was last serviced on (b)(6) 2011 when no issues were noted with the sterilizer. Steris conducted in-service training regarding proper use and operation of the equipment on (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2011-00035 |
| MDR Report Key | 2374292 |
| Report Source | 06 |
| Date Received | 2011-12-14 |
| Date of Report | 2011-12-14 |
| Date of Event | 2011-11-14 |
| Date Mfgr Received | 2011-11-15 |
| Date Added to Maude | 2011-12-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MS LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| Manufacturer G1 | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Street | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE |
| Manufacturer City | GUADALUPE, NUEVO LEON 67190 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 67190 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3017 ETO STERILIZER |
| Generic Name | STERILIZER, ETHYLENE-OXIDE GAS |
| Product Code | FLF |
| Date Received | 2011-12-14 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Address | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE GUADALUPE, NUEVO LEON 67190 MX 67190 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-14 |