MAUDE Adverse Event Report: CORPORATION STERIS CANADA SYSTEM 1 ENDO; SYSTEM 1 ENDO LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

Model Number	1 ENDO
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system 1 endo liquid chemical sterilant processing system subject of the reported event is being returned for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their system 1 endo liquid chemical sterilant processing system would not drain properly and had trouble opening the door.Patient procedures were subsequently postponed.No report of injury.
Additional Manufacturer Narrative
The system 1 endo liquid chemical sterilant processing system subject of the reported event was returned for evaluation.The unit was evaluated and following a thorough review, a root cause could not be determined.The device history record was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.The user facility was provided a replacement system 1 endo liquid chemical sterilant processing system.No additional issues have been reported.

• Brand Name: SYSTEM 1 ENDO
• Common Device Name: SYSTEM 1 ENDO LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
• 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: 20919283
• Report Number: 9680353-2024-00042
• Device Sequence Number: 8391431
• Product Code: MED
• UDI-Device Identifier: 00724995170554
• UDI-Public: (01)00724995170554(11)240826
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/12/2024

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: 11/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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