MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 3017 EO GAS STERILIZER

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that their eo gas sterilizer alarmed.No injury was reported.

Manufacturer Narrative

A steris service technician arrived onsite and put the sterilizer in service mode to pull any remaining eo gas in the chamber.Before the technician's arrival the gas was contained in the sterilizer and the sterilizer operated properly to pull a vacuum after a cycle alarm.The technician opened the sterilizer door and found the gas canister needle still in the canister.When the technician removed the canister from the sterilizer the eo monitor located behind the sterilizer alarmed due to proximity of the canister to the alarm.Due to the alarm, the room was evacuated.The technician stated that a valve was not functioning properly causing the needle to puncture the gas canister out of sequence subsequently causing gas to release before the sterilization phase.The technician repaired the unit, ran a test cycle and confirmed it to be operational.No additional issues have been reported.

• Brand Name: 3017 EO GAS STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4571972
• MDR Text Key: 21727342
• Report Number: 3005899764-2015-00014
• Device Sequence Number: 1
• Product Code: FLF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1