MAUDE Adverse Event Report: CORPORATION STERIS CANADA SYSTEM 1 ENDO

Model Number	1 ENDO
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Upper Respiratory Tract Irritation (4872)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the system 1 endo.The technician found that the inflatable door seal required replacement.As the inflatable door seal was not operating properly, water with sterilant leaked from the unit's door onto the floor.The technician replaced the inflatable door seal, tested the unit, confirmed it to be operating according to specifications, and returned it to service.A 3-year complaint review confirmed the reported event to be isolated.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a cycle for their system 1 endo, water with sterilant leaked out onto the floor.User facility personnel present in the area experienced "respiratory issues" and went to the emergency department.It is unknown if treatment was administered.

• Brand Name: SYSTEM 1 ENDO
• Common Device Name: SYSTEM 1 ENDO
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 22103969
• Report Number: 9680353-2025-00023
• Device Sequence Number: 8140496
• Product Code: MED
• UDI-Device Identifier: 00724995170554
• UDI-Public: (01)00724995170554(11)220322
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K232914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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: 04/29/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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