MAUDE Adverse Event Report: STERIS CANADA ULC SYSTEM 1E PROCESSOR

Model Number	1E
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the system 1e processing system and found no issues with the function or operation of the device.The employee subject of the reported event was only wearing goggles and gloves while handling the s40 sterilant concentrate container.The s40 sterilant concentrate safety data sheet (sds), states that users should wear a face shield, corrosion-proof clothing, gloves, and protective goggles.Respiratory protection is recommended in case of insufficient ventilation to prevent adverse effects from inhalation of peracetic acid vapors.The steris technician counseled user facility personnel on safe operating protocols and the importance of wearing appropriate ppe.A copy of the s40 sterilant concentrate safety data sheet (sds) was also provided to the user facility.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee experienced irritation/inhalation after placing the s40 sterilant concentrate container into the sterilant compartment in the system 1e and inserting the aspirator probe over the sterilant container lid.The employee was sent to the er and received a medical exam.

• Brand Name: SYSTEM 1E PROCESSOR
• Common Device Name: SYSTEM 1E PROCESSOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16731420
• Report Number: 9680353-2023-00011
• Device Sequence Number: 17817628
• Product Code: MED
• UDI-Device Identifier: 00724995092986
• UDI-Public: 00724995092986
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1E
• Device Catalogue Number: 6500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown