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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the atlas transfer carriage.While onsite, the technician was informed that a cart detached from the track of the transfer carriage and tipped into a sterilizer as the employee was loading the sterilizer.The employee attempted to lift the cart and subsequently sustained an injury.After inspecting the units, the technician determined that the transfer carriage was damaged.The transfer tab was bent and missing a weldment causing the cart to detach from the track of the transfer carriage.The transfer carriage was installed in 2007 is not under steris service agreement for preventive maintenance activities.The technician counseled user facility personnel on proper use, operation, and maintenance of the atlas transfer carriage.The technician provided the user facility with a quote for the necessary repairs.Steris is awaiting the user facility's response.

Event Description

The user facility reported that an employee was injured while operating their atlas transfer carriage.Medical treatment was sought and administered.No procedure delay or cancellation was reported.

Manufacturer Narrative

On 12/10/2018, the technician confirmed that the necessary repairs were completed.The technician tested the transfer carriage, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

• Brand Name: ATLAS TRANSFER CARRIAGE
• Type of Device: TRANSFER CARRIAGE TO STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• MDR Report Key: 8071186
• MDR Text Key: 128282816
• Report Number: 3005899764-2018-00099
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1