MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 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	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the internal steam generator had cracks along the welding.The technician also found scale build up within the steam generator due to the facility water quality.As the steam generator had cracks along the welding, this allowed water to leak from the unit.The unit has been removed from service as it is pending repairs.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that water was leaking from their evolution sterilizer onto the floor.No report of injury.Report of procedure delays.
Additional Manufacturer Narrative
Due to the damage that the steam generator sustained, the steris service technician replaced the steam generator, tested the function and operation of the device, and confirmed it to be operating according to specifications.The evolution sterilizer was returned to service and no additional issues have been reported.A steris service technician collected water samples to be tested.The results identified that three of the critical chemical attributes of water quality were above the maximum requirements for the electric steam generator as stated in the medium evolution sterilizer operator manual (table 7-3.Required feed water quality for carbon steel generators).The user facility is responsible for ensuring that their incoming water supply remains within the electric steam generator's operating requirements.The medium evolution sterilizer operator manual states (3-1), "water quality - supplied must be within specifications.Improper water quality adversely affects equipment operation." the technician notified the customer of the water quality test results and that their water quality is not meeting the required operating conditions.No additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: AMSCO EVOLUTION
• 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
• MDR Report Key: 18006779
• Report Number: 3005899764-2023-00055
• Device Sequence Number: 15114100
• Product Code: FLE
• UDI-Device Identifier: 00724995151515
• UDI-Public: (01)00724995151515(11)161107(21)033121621
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/25/2023

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: UE02
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 09/28/2023; Not provided
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/29/2024; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2016
• 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