MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 600 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	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that water was leaking from their amsco 600 sterilizer onto the floor.No report of injury.
Additional Manufacturer Narrative
On 4/5/2023, a steris service technician arrived onsite to inspect the unit and found that the drainpipe hose had detached from the unit allowing water to leak from the sterilizer resulting in the reported event.The technician reinstalled the drainpipe hose, tested the sterilizer, confirmed it to be operating according to specification, and returned it to service.On (b)(4)2023, the customer contacted steris and stated that water and steam was leaking from their amsco 600 sterilizer onto the floor.A steris service technician arrived onsite to inspect the unit and found that the jacket safety valve was open, allowing steam to leak from the sterilizer.The jacket safety valve opened in order to relieve pressure within the jacket as designed.Further investigation determined that the temperature sensor required calibration which is what caused the jacket safety valve to open allowing steam to leak from the sterilizer.The technician calibrated the temperature sensor and made the necessary adjustments to the jacket safety valve, tested the unit, confirmed it to be operating according to specification and returned it to service.No additional issues have been reported.

• Brand Name: AMSCO 600 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: 16863321
• Report Number: 3005899764-2023-00025
• Device Sequence Number: 6040856
• Product Code: FLE
• UDI-Device Identifier: 00724995179199
• UDI-Public: 00724995179199
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/03/2023

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: EF1101140
• 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: 04/05/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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