MAUDE Adverse Event Report: STERIS CANADA ULC SYSTEM 1 ENDO

Model Number	1 ENDO
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the system 1 endo system.The technician ran a cycle and found no issues with the function or operation of the unit.The technician was unable to duplicate the reported event.The technician confirmed that no issues were noted with the latching mechanism on the system 1 endo system's lid.When the cycle was started and the door seal inflated, if the latches were not fully engaged, the seal inflation could have been enough upward force to cause them to pop open and release the lid.As no issues were noted with the system 1 endo system, the reported event may be attributed to the endoscope not being loaded properly subsequently causing the lid latches from latching securely.The operator manual states (5-3), "warning: failure to properly position devices so that all surfaces will be exposed to the liquid sterilant or overloading the processing container may result in an ineffective liquid chemical sterilization and/or damage the devices." the steris technician counseled user facility personnel on the proper operation on the system 1 endo system and the importance of properly loading the unit and ensuring the lid is closed and latched properly.The technician ran a test cycle and returned the system 1 endo system to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a processing cycle for their system 1 endo system, the lid "popped" opened subsequently causing liquid to leak out of the unit and onto the floor.User facility personnel proceeded to clean up the liquid and in the process experienced inhalation/irritation.One of the employees obtained a burn on her forearm and sought and received medical treatment.

• Brand Name: SYSTEM 1 ENDO
• Common Device Name: SYSTEM 1 ENDO
• 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: 16330456
• Report Number: 9680353-2023-00004
• Device Sequence Number: 6817210
• Product Code: MED
• UDI-Device Identifier: 00724995170554
• UDI-Public: 00724995170554
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/08/2023

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: 1 ENDO
• Device Catalogue Number: P6900
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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