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

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Insufficient Information (4580)

Event Date 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation of the subject event is in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that an employee experienced throat irritation and obtained a burn on their hand while removing an s40 sterilant cup from their system 1e processor.The facility did not disclose if medical treatment was sought or administered.

Manufacturer Narrative

Through additional follow-up with user facility personnel, we learned an employee experienced throat irritation and obtained a burn on their hand while removing an s40 sterilant cup from their system 1e and disposing of the cup in the trash after running a diagnostic cycle instead of a processing cycle in their system 1e processor.The facility did not disclose if medical treatment was sought or administered.During the time of the reported event, the employee had run a diagnostic cycle with a s40 sterilant cup in the unit.The purpose of the diagnostic cycle is to verify the proper functioning of the processor.The system 1e operator manual states (1-3), "never use sterilant for the diagnostic cycle." in regard to the employee injury, the employee did not properly dispose of the partially filled s40 sterilant cup or wear proper ppe, specifically gloves, as stated in the operator manual.The system 1e operator manual (3-4) contains detailed instructions on automated or manual disposal of a partially filled sterilant cup.Additionally, regarding ppe, the operator manual states (3-4), "to dispose of partially filled, leaking, damaged, or expired sterilant containers, put on appropriate personal protective equipment (chemical-resistant gloves, apron, goggles or face shield, and any other protection required by facility procedures).Wear protective attire for the entire procedure." a steris technician tested the unit, confirmed it was operating according to specifications, and returned the unit to service.Refresher in-service training for the hospital regarding proper use and operating protocols, specifically ensuring that employee's wear proper ppe when handling s40 sterilant cups, the proper disposal of s40 sterilant cups, and the importance of not using s40 sterilant in a diagnostic cycle.No additional issues have been reported.

• 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 road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 13674907
• MDR Text Key: 290951585
• Report Number: 9680353-2022-00005
• Device Sequence Number: 1
• Product Code: MED
• 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,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• 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