MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; AMSCO 400 STEAM STERILIZER

Model Number	AMSCO 400 STEAM STERILIZER
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported an employee suffered an injury after a door panel fell on their feet while operating a medium amsco 400 sterilizer.The employee received medical treatment; however, it is unknown what type of treatment was administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the door was opening past the appropriate limit, subsequently causing the side panel, door shell, hinges and connecting bracket to bend.While bending, the connecting bracket pushed the lower door panel downward, causing the panel to release and fall onto the affected employee's feet.To resolve the issue, the technician adjusted the door stop to prevent the door from opening beyond the appropriate limit and repaired the panels and brackets.The unit was confirmed to be operating according to specification and returned to service.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: AMSCO 400 STEAM 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: 20402503
• Report Number: 3005899764-2024-00054
• Device Sequence Number: 6479882
• Product Code: FLE
• UDI-Device Identifier: 00724995210588
• UDI-Public: (01)00724995210588(11)230425
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K212424
• 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): 10/08/2024

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: AMSCO 400 STEAM STERILIZER
• Device Catalogue Number: SR2321213011
• 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: 09/09/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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