MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

Model Number	AMSCO 400 Steam Sterilizer
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility medwatch indicated this event occurred on (b)(6) 2022.A review of our service records indicates there were no requests for service received from the customer in regard to a door panel issue from (b)(6) 2022 to present date.A steris district service manager has contacted the customer for additional information regarding the reported event.To date, we have not received a response from the customer.The sterilizer subject of the event was installed in 2018 and is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.On may 26, 2022, steris performed a billable preventive maintenance on the sterilizer per the request of the customer.Preventive maintenance is scheduled two times per year for the amsco 400 sterilizer.The amsco 400 sterilizer operator manual states (1-3), "warning: personal injury hazard and/or equipment damage hazard: caution - possible equipment damage: regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment.Contact your steris service representative to schedule preventive maintenance." our most recent service request from the customer for the unit subject of this event was in november 2022 and the unit had repairs performed unrelated to the door.Following the repairs, the unit was tested, confirmed to be operating according to specifications, and returned to service.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 report #(b)(4) that the panel for their amsco 400 sterilizer door hinge cover is getting caught on the door causing the door to become damaged and difficult to open and close.No report of injury.

• Brand Name: AMSCO 400 STERILIZER
• 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 ; 4403927453
• MDR Report Key: 15843787
• Report Number: 3005899764-2022-00056
• Device Sequence Number: 6996310
• Product Code: FLE
• UDI-Device Identifier: 00724995210137
• UDI-Public: 00724995210137
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 11/22/2022

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 400 Steam Sterilizer
• Device Catalogue Number: SR2221211011
• 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: 10/25/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2018
• 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