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

Device Problem Device Fell (4014)

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

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on site to inspect the unit and found the unit had been damaged due to the reported event.Due to the damage of both the transfer carriage and docking station, the technician was unable to test the functionality of the transfer carriage.Based on the description of the event, the employee did not properly align the transfer carriage with the sterilizer's docking station causing an inadequate latch of the transfer carriage's front wheels resulting in the reported event.The technician counseled user facility personnel on the proper use and operation of the evolution transfer carriage, specifically properly engaging the transfer carriage with the docking station.Due to the damage, the transfer carriage will be replaced as a result of the event.No additional issues have been reported.

Event Description

The user facility reported that while an employee was unloading their sterilizer, the evolution transfer carriage fell to the ground.No report of injury.

Manufacturer Narrative

The transfer carriage subject of the event was replaced.No additional issues have been reported.

• Brand Name: EVOLUTION TRANSFER CARRIAGE
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• MDR Report Key: 10759110
• MDR Text Key: 215317629
• Report Number: 3005899764-2020-00075
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1