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

Model Number	HC-1500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the bolts that attach the panel to the sterilizer were not secure causing the reported event to occur.The technician replaced and secured the bolts, tested the unit, confirmed it to be operating according to specification and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that the top panel on their 60" evolution sterilizer fell off the unit contacting an employee's head.Medical treatment was sought and administered.The user facility did not disclose what medical treatment was administered.
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: 18125399
• Report Number: 3005899764-2023-00064
• Device Sequence Number: 6439988
• Product Code: FLE
• UDI-Device Identifier: 00724995151522
• UDI-Public: (01)00724995151522(11)191218(21)033521906
• 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
• Report Date (Section B): 11/13/2023

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-1500
• Device Catalogue Number: UE06
• 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: 10/14/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2019
• 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