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

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event.After speaking with the user facility, the technician was informed that the employee did not ensure the transfer carriage wheels were properly locked into the docking station when removing a load from the sterilizer.The technician found that the transfer carriage required adjustment due to damage as a result of the reported event.The technician made the necessary adjustments to the transfer carriage, tested the unit, confirmed it to be operating properly, and returned it to service.The technician counseled facility personnel on the proper use and operation of the transfer carriage and docking station, specifically, ensuring the wheels are properly locked to the docking station.No additional issues have been reported.

Event Description

The user facility reported that an employee was unloading a processed load from the sterilizer with their evolution transfer carriage when the carriage became unstable and fell to the floor.No report of injury.

• Brand Name: EVOLUTION TRANSFER CARRIAGE
• Type of Device: 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 ; 4403927453
• MDR Report Key: 11240334
• MDR Text Key: 238401725
• Report Number: 3005899764-2021-00003
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2020
• 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