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

Model Number	AX0660230830000013
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown the exact transfer carriage facility personnel were using during the time of the reported event; the user facility has eight atlas transfer carriages: (b)(4).A steris service technician arrived onsite to inspect the sterilizer and transfer carriage and learned that during the time of the reported event the employee was attempting to move the loading car that sits on the transfer carriage from the sterilizer and injured their back.It is likely that the loading car was not properly aligned with the sterilizer railing when the employee tried to pull the loading car from the sterilizer.The employee then tried to manually lift the transfer carriage to align it with the sterilizer's rails.While on site, the technician inspected the area where the unit was located and stated that the misalignment between the sterilizer and transfer carriage was due to the floors being uneven.Depending on the degree of the floor unevenness, if an employee tried to use the carriage on a different sterilizer, it could have damaged the latching mechanism or not allowed the latching mechanism to engage and disengage properly as the carriage may not be properly adjusted for the sterilizer.The steris technician made user facility personnel aware of this.The atlas loading car and atlas transfer carriage is not under steris service agreement.Section 2.5 of the operator/maintenance manual states the following, "warning - personal injury hazard: rails on transfer cart must be leveled front to rear, and aligned vertically and horizontally with tracks inside sterilizer.Failure to adjust transfer cart rails as presented in this manual may result in injury to personnel or damage to product and equipment." the technician counseled the customer on the proper leveling of the transfer carriage.A two-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee was injured while moving their atlas transfer carriage.No report of procedure delay.Medical treatment was sought and administered (surgery).

• Brand Name: ATLAS
• Common Device Name: TRANSFER CARRIAGE
• 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: 19950106
• Report Number: 3005899764-2024-00037
• Device Sequence Number: 21073330
• Product Code: FLE
• UDI-Device Identifier: 00724995150631
• UDI-Public: (01)00724995150631
• 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): 08/09/2024

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: 07/11/2024
• Initial Report FDA Received Date: 08/09/2024
• 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