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 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the transfer carriage and found that the docking station was damaged preventing the transfer carriage from locking properly.Facility personnel were aware that the docking station was damaged prior to the event and continued use of the docking station.The user facility did not contact steris prior to the reported event for service.The user facility personnel should have removed the unit from service.The technician counseled facility personnel on proper use and operation of the transfer carriage, specifically removing the unit from service if it is damaged and contacting steris to perform necessary service.Due to the damage, the docking station was replaced.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 floor and the employee was contacted.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: 10652291
• MDR Text Key: 214789037
• Report Number: 3005899764-2020-00067
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/08/2020
• 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