MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE

Device Problem Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the transfer carriage and found the transfer carriage was damaged.The unit was not operational.A replacement unit will be installed.The unit subject of this event will be returned to steris for evaluation.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported their evolution transfer carriage fell to the ground prior to removing a processed load from the sterilizer.No report of injury.

Manufacturer Narrative

The transfer carriage subject of this event was returned to steris for evaluation and it was determined that the set screws of the front leg and caster assembly of the transfer carriage were loose.As the set screws were loose, the front leg and caster assembly was able to become unlocked resulting in the reported event.The root cause of the reported event is impact damage by facility personnel subsequently allowing the set screws to become loose.The technician counseled facility personnel on the proper use and operation of the transfer carriage, including the importance of not bumping the transfer carriage into other equipment.A replacement unit was installed and no additional issues have been reported.

• Brand Name: 66" 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
• MDR Report Key: 10015497
• MDR Text Key: 199555212
• Report Number: 3005899764-2020-00028
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1