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

Model Number	AMSCO 400 STEAM STERILIZER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After chamber cleaning was completed by user facility personnel, they attempted to drain the cleaning chemical from the unit.Per the amsco 400 series steam sterilizer operator manual, standing liquid can be drained by initiating a cycle and immediately aborting it.User facility personnel followed this process, however, after the cycle was aborted a small amount of cleaning chemical remained.User facility personnel repeated the process, however, did not immediately abort the cycle as instructed.This caused steam to mix with the remaining cleaning chemistry.An employee then opened the sterilizer door, and a mixture of steam and chemical emitted from the unit, subsequently causing the reported event.A steris service technician arrived onsite following the reported event to inspect the unit and found the unit to be operating properly.The technician was unable to recreate the reported event, and the unit was returned to service.The amsco 400 series steam sterilizers operator manual states, "if the water does not drain completely, it may be necessary to initiate a cycle and immediately abort it.The cycle/abort action opens the sterilizer drain, draining the water from the chamber." user facility personnel were counseled on the proper use and operation of the amsco 400 sterilizer.No additional issues have been reported.
Event or Problem Description
The user facility reported that multiple employees experienced dizziness and lightheadedness after cleaning the chamber of their amsco 400 sterilizer.The employees visited the er.It is unknown if type of medical treatment was administered.

• Brand Name: AMSCO
• Common Device Name: AMSCO 400 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: 20537508
• Report Number: 3005899764-2024-00060
• Device Sequence Number: 8247841
• Product Code: FLE
• UDI-Device Identifier: 00724995209667
• UDI-Public: (01)00724995209667(11)171228
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 10/25/2024

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: SR0202310321
• 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: 09/26/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2017
• 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