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	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the sterilizer and found a leak from piping above the sterilizer from the ro water system.The ro water connection is located above the sterilizer, connecting the sterilizer to deionized water.The ro connection was found to be loose causing a leak, resulting in the reported event.The technician contacted the customer's biomed third party to make the necessary repairs to the unit.The reported event is attributed to improper preventive maintenance activities by user facility personnel.After the repairs were made, the unit was tested, confirmed to be operating according to specification, and was returned to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee slipped and fell on water that had leaked onto the floor from their amsco 600 sterilizer.The employee sought medical treatment however, no medical treatment was administered.

• 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: 15422663
• Report Number: 3005899764-2022-00042
• Device Sequence Number: 20021075
• Product Code: FLE
• UDI-Device Identifier: 00724995179427
• UDI-Public: 00724995179427
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/14/2022

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: EF1201242
• 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: 08/15/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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