MAUDE Adverse Event Report: CORPORATION STERIS CANADA SYSTEM 1 ENDO

Model Number	1 ENDO
Medical Device Problem Codes	Failure to Align (2522); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their system 1 endo liquid chemical sterilant processing system was leaking water.No report of injury.
Additional Manufacturer Narrative
Investigation in progress.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the system 1 endo liquid chemical sterilant processing system and found the door was misaligned which caused the lid to not sit properly resulting in the reported leak.The technician attempted to repair the unit; however, due to the damage sustained the unit was permanently removed from service and a new unit was installed and placed into service.A 3-year complaint review confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that their system 1 endo liquid chemical sterilant processing system was leaking water.As a result, instruments had to be reprocessed resulting in procedure delays.No report of injury.

• 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: 21709181
• Report Number: 9680353-2025-00014
• Device Sequence Number: 21320311
• Product Code: MED
• UDI-Device Identifier: 00724995170554
• UDI-Public: (01)00724995170554(11)241029
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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