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

Model Number	AMSCO 600 STEAM STERILIZER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and reviewed the unit's cycle printout.The cycle printout identified that the sterilizer had displayed a pressure alarm and a door unseal alarm.The alarms are indicative that the facility's steam pressure was too low.Additionally, the cycle printout showed that the unit was placed into service mode during the time of the reported event.Based on the cycle printout and technician's inspection, it is likely that following the alarms, the cycle aborted.User facility personnel then placed the unit into service mode to open the sterilizer door resulting in the reported event.The user facility should not have placed the unit into service mode but rather followed the instructions as per the operator manual.The amsco 600 sterilizer operator manual states (pg.90), "silence alarm, request maintenance to verify steam pressure is 50 - 80 psig, and contact steris".To resolve the issue, the technician proactively calibrated the unit.The unit was tested, confirmed to be operating according to specifications, and returned to service.While onsite the technician counseled user facility personnel on the proper use and operation of the amsco 600 sterilizer.No additional issues have been reported.
Event or Problem Description
The user facility reported that their amsco 600 sterilizer leaked water onto the floor.No report of injury.

• Brand Name: AMSCO
• 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
• MDR Report Key: 22521567
• Report Number: 3005899764-2025-00058
• Device Sequence Number: 8164442
• Product Code: FLE
• UDI-Device Identifier: 00724995179069
• UDI-Public: (01)00724995179069(11)201229
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 07/16/2025

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 600 STEAM STERILIZER
• Device Catalogue Number: EF1101210
• 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: 06/16/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2020
• 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