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 Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the employee was loading instruments when one of the wheels fell off the transfer carriage subsequently allowing the transfer carriage to fall to the floor.The user facility did not disclose if the instruments subject of the event were reprocessed prior to use.A steris service technician arrived onsite to inspect the transfer carriage and found that the wedges had become loose subsequently causing the wheel to fall off.The technician performed the necessary repairs to reattach the wheel, tested the unit, confirmed it to be operating according to specification, and returned it to service.The unit was installed in 2016 and is not under steris service agreement.The user facility is responsible for all maintenance activities.No additional issues have been reported.

Event Description

The user facility reported that an employee was injured while operating their atlas transfer carriage.

• 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
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8409825
• MDR Text Key: 139329017
• Report Number: 3005899764-2019-00022
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1