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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The february 2024 preventive maintenance service request tickets for the subject amsco 600 steam sterilizers ((b)(4)) were opened on 1/30/2024.The steris service technician was aware of the backordered parts to complete the preventive maintenance (pm) activity and was unable to complete the pms until all components were available.All pm activities for the units were completed in march 2024 and the amsco 600 steam sterilizers were returned to service.No further service activities have been requested by the user facility.The user facility proceeded to file medwatch mw5155875, mw5155876 and mw5155877 reports which steris received on june 28, 2024.The amsco 600 steam sterilizers subject of the reported event were manufactured in 2021.The user facility purchased installation of the amsco 600 steam sterilizers in 2023.The installation of the units were completed by steris in september 2023.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch reports mw5155875, mw5155876 and mw5155877 that "pms of 3 sterilizers were closed outside the month +/- 10 day window for completing scheduled planned maintenance.This was due to the contracted oems inability to produce the pm kits needed for the equipment due for pm.".

• 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: 19828618
• Report Number: 3005899764-2024-00034
• Device Sequence Number: 8150130
• Product Code: FLE
• UDI-Device Identifier: 00724995179632
• UDI-Public: (01)00724995179632
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/25/2024

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 600 STEAM STERILIZER
• Device Catalogue Number: EF1301142
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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