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

Model Number	AMSCO 600 STEAM STERILIZER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the amsco 600 sterilizer and found that the water hose from the pure water line had disconnected subsequently causing the reported event to occur.The steris service technician further inspected the hose and found that the hose had an incorrect fitting specifically, the hose clamp was not crimped.This is intended to be done during the installation process.The steris service technician replaced the hose, tested the function and operation of the amsco 600 sterilizer, confirmed it to be operating properly, and returned it to service.Additionally, the service technician confirmed proper hose install and fittings for all amsco 600 sterilizers at the user facility.No other issues were identified.The steris service technician who installed the amsco 600 sterilizer was retrained on the proper installation procedures and the importance of ensuring the hose is properly crimped and secured.No additional issues have been reported.
Event or Problem Description
The user facility reported that water was leaking from their amsco 600 sterilizer.No report of injury.

• Brand Name: AMSCO
• Common Device Name: AMSCO 600 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: 20527749
• Report Number: 3005899764-2024-00056
• Device Sequence Number: 7969501
• Product Code: FLE
• UDI-Device Identifier: 00724995179519
• UDI-Public: (01)00724995179519(11)240408
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 10/24/2024

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: EF1301122
• 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: 09/24/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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