MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 42" EVOLUTION TRANSFER CARRIAGE

Device Problems Unstable (1667); Device Fell (4014)

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

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the transfer carriage and found the set screws for 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 attributed to impact damage by user facility personnel subsequently allowing the set screws to become loose.The technician installed new set screws, tested the unit, confirmed it to be operating according to specification, and returned it to service.The technician counseled facility personnel on the proper use and operation of the transfer carriage.No additional issues have been reported.

Event Description

The user facility reported that an employee was unloading instruments with their evolution transfer carriage when the carriage became unstable resulting in the loading car and carriage to fall to the floor.No report of injury.

• Brand Name: 42" 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: 9180415
• MDR Text Key: 199550786
• Report Number: 3005899764-2019-00085
• 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,Followup
• Report Date: 10/11/2019

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: 09/11/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 10/18/2019
• 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