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

Model Number	AMSCO 400 STEAM STERILIZER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the water manifold bolt was damaged, causing the reported event.To resolve the issue, the technician replaced the bolt.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 regulation of the water pressure for the amsco 400 sterilizer.No additional issues have been reported.
Event or Problem Description
The user facility reported a water leak onto the floor from their amsco 400 sterilizer.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: 20304721
• Report Number: 3005899764-2024-00049
• Device Sequence Number: 7624041
• Product Code: FLE
• UDI-Device Identifier: 00724995209537
• UDI-Public: (01)00724995209537(11)221228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/25/2024

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: SR0201210311
• 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: 08/26/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• 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