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	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that following an aborted cycle, an employee suffered a burn to their face and a blister on their lip when their face contacted steam after opening their amsco 400 sterilizer door.The employee sought medical treatment and was given ice.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found a hole in the valve diaphragm which caused poor level vacuums and led to the unit aborting.To resolve the issue, the technician replaced the valve.The unit was tested, confirmed to be operating according to specification, and returned to service.A 3-year complaint review indicates this is an isolated event.The amsco 400 series small steam sterilizer operator manual states (pg.6-3), "warning - burn hazard: steam may be released from the chamber when door is opened.Step back from the sterilizer each time the door is opened to minimize contact with steam vapor." the technician counseled the user facility about the importance of stepping back from the sterilizer each time the door is opened.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: 20368943
• Report Number: 3005899764-2024-00052
• Device Sequence Number: 6869255
• Product Code: FLE
• UDI-Device Identifier: 00724995209254
• UDI-Public: (01)00724995209254(11)180222
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 10/04/2024

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: SR0101110311
• 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: 09/06/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• 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