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

Model Number 1E

Device Problem Use of Device Problem (1670)

Patient Problem Burning Sensation (2146)

Event Date 02/14/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 313203179
• Report Number: 9680353-2023-00011
• Device Sequence Number: 1
• Product Code: MED
• UDI-Device Identifier: 00724995092986
• UDI-Public: 00724995092986
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1E
• Device Catalogue Number: 6500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• 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