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

Model Number	AMSCO 400 STEAM STERILIZER
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the transfer carriages and found that some of the front wheels were loose.Due to the loose wheels, the transfer carriage did not properly align with the docking station when loading and unloading the loading car.Additionally, the technician found that the track rails within the sterilizer's chamber required replacement.The issues identified with the transfer carriage and sterilizer caused the loading car to not properly align with the track rails subsequently resulting in the reported event.The steris service technician tightened the wheels on the transfer carriages and returned them to service.The track rails on the amsco 400 sterilizer are pending replacement.A follow-up mdr will be submitted once the repairs have been completed.
Event or Problem Description
The user facility reported that they were having difficulty loading and unloading their amsco 400 sterilizer with their transfer carriages.One employee stated that her wrist became sore.The employee self-treated with ice and ibuprofen.
Additional Manufacturer Narrative
The technician installed new track rails, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

• Brand Name: AMSCO 400 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: 16591130
• Report Number: 3005899764-2023-00016
• Device Sequence Number: 17415399
• Product Code: FLE
• UDI-Device Identifier: 00724995210847
• UDI-Public: 00724995210847
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 03/22/2023

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: AMSCO 400 STEAM STERILIZER
• Device Catalogue Number: SR2326313021
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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