MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 54" EVOLUTION STERILIZER

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the 54" evolution sterilizer and found the door pivot bolt to be missing from its location.The technician removed the sterilizer from service and is pending repairs.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that an employee obtained an injury to their shoulder while opening the door to their 54" evolution sterilizer.The employee was sent to the er.It is unknown if medical treatment was administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the sterilizer and found that the door pivot stud had come off subsequently causing the door plates to become misaligned and the door to bind making it difficult to open.Steris is unable to determine when the door pivot stud came off subsequently causing the reported event to occur.As the door pivot stud was not present, a root cause could not be determined.In lieu of repairing the unit, the customer received a new unit.The new unit was installed, confirmed to be operational and placed into service.No additional issues have been reported.

• Brand Name: 54" 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
• MDR Report Key: 17608343
• Report Number: 3005899764-2023-00041
• Device Sequence Number: 7365040
• Product Code: FLE
• UDI-Device Identifier: 00724995151515
• UDI-Public: 00724995151515
• 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): 08/23/2023

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
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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