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

Model Number	AX0660230830000013
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the loading carriage was not aligned to the rail inside the sterilizer.The technician noted that the loading carriage was misaligned due to the wear on the front wheels of the loading carriage.The unit is not under steris contract for maintenance services.To resolve the issue, the technician replaced the wheels and adjusted the rail and carriage height inside the sterilizer.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee injured their shoulder while operating an atlas transfer carriage.Medical treatment was sought and administered.It is unknown what type of medical treatment was administered.

• Brand Name: ATLAS
• 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: 19810636
• Report Number: 3005899764-2024-00033
• Device Sequence Number: 8379558
• Product Code: FLE
• UDI-Device Identifier: 00724995150631
• UDI-Public: (01)00724995150631
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/19/2024

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: AX0660230830000013
• Device Catalogue Number: AX0660230830000013
• 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: 06/19/2024
• Initial Report FDA Received Date: 07/23/2024
• 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