MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. EVOLUTION STERILIZER

Model Number	HC-1200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found the view port was damaged allowing water and steam to leak from the sterilizer.The technician replaced the view port and pressure switch, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that water and steam were leaking from their evolution sterilizer onto the floor.No report of injury.
Additional Manufacturer Narrative
A steris service technician collected water samples to be tested.The results identified that 3 of the critical chemical attributes of water quality were above the maximum requirements for the evolution sterilizer.The user facility is responsible for ensuring that their electric steam generator water remains within the electric steam generator's operating requirements.The technician notified the customer of the water quality test results and that their water quality is not meeting the required operating conditions.The user facility has committed to making the necessary improvements to the facility's incoming water quality.No additional issues have been reported.

• Brand Name: EVOLUTION STERILIZER
• Common Device Name: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 13440439
• Report Number: 3005899764-2022-00002
• Device Sequence Number: 4327391
• Product Code: FLE
• UDI-Device Identifier: 00724995151508
• UDI-Public: 00724995151508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 02/03/2022

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: HC-1200
• Device Catalogue Number: UE05
• 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: 01/07/2022
• Supplement Date Received by Manufacturer: 01/07/2022; 01/07/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/19/2022; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2019
• 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