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

Model Number	HC-1200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the sterilizer and found that the bolts that attach the top panel to the sterilizer were missing.As the bolts were missing, the top panel was not properly secure subsequently causing the panel to fall and contact the employee.The technician secured the top panel, tested the sterilizer, confirmed the unit 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 to their 54" evolution sterilizer fell off after an employee closed the sterilizer's door.As the panel fell, the employee tried to catch it and it contacted their nose.The employee also sustained an injury to their shoulder.Medical treatment was sought and administered (ice pack).

• 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: 16375385
• Report Number: 3005899764-2023-00005
• Device Sequence Number: 15268609
• Product Code: FLE
• UDI-Device Identifier: 00724995151508
• UDI-Public: 00724995151508
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/14/2023

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: 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: 01/13/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2017
• 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