MAUDE Adverse Event Report: STERIS CANADA ULC SYSTEM 1 ENDO

Model Number	1 endo
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained a burn while handling a cup of s40 sterilant concentrate.The employee sought and received medical treatment.
Additional Manufacturer Narrative
User facility personnel stated that the employee subject of the reported event punctured the s40 sterilant concentrate cup prior to placing it into their system 1 endo system.The employee should not have punctured the s40 sterilant concentrate cup prior to placing it in the system 1 endo system.The user is only instructed to remove the s40 sterilant concentrate cup from the carton and then place it into the system 1 endo system.The operator manual states (pg.7-2), "open the sterilant carton at the tear notch and remove the container." "place the sterilant container into the sterilant compartment which is located in the lower right hand corner of the processing tray." the employee subject of the reported event was counseled on the proper handling of s40 sterilant concentrate and the operating procedures for the system 1 endo system.

• 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: 16028938
• Report Number: 9680353-2022-00030
• Device Sequence Number: 5476857
• Product Code: MED
• UDI-Device Identifier: 00724995170554
• UDI-Public: 00724995170554
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 12/21/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/21/2022
• Date Device Manufactured: 01/18/2022
• 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