MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; AMSCO 600 STERILIZER

Model Number	AMSCO 600 STEAM STERILIZER
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their amsco 600 sterilizer has had intermittent issues resulting in procedure cancellations.No report of injury.
Additional Manufacturer Narrative
Our investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived on-site to inspect the amsco 600 sterilizer and found that the unit's air pressure was below the specified limit, and that the door proximity switches and door pressure set points required adjustment.The technician installed an air filter for the sterilizer and made the necessary door assembly adjustments, confirmed the unit to be operating according to specifications, and returned it to service.The device history record was reviewed and confirmed the unit was manufactured according to specifications; no abnormalities were noted.A 3-year complaint review determined this to be an isolated event.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: AMSCO 600 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 ; 4402597401
• MDR Report Key: 22841918
• Report Number: 3005899764-2025-00070
• Device Sequence Number: 9463669
• Product Code: FLE
• UDI-Device Identifier: 00724995179472
• UDI-Public: (01)00724995179472(11)241220
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/19/2025

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 600 STEAM STERILIZER
• Device Catalogue Number: EF1301110
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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