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

Device Problem Device Fell (4014)

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

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived to inspect the transfer carriage following the reported event.The technician was informed that after placing the load into the sterilizer the transfer carriage fell onto the docking station; causing the frame of the transfer carriage and docking station to become damaged.The technician was unable to test functionality of the transfer carriage as it became damaged due to the reported event.Based on the description of the event, it is likely that the employee did not confirm that the transfer carriage was appropriately aligned with the sterilizer's docking station.The 66" transfer carriage operator manual states (pg.1-2), "ensure docking base is properly aligned to allow correct entry of loading car into chamber before permanently fastening base to floor.".The transfer carriage was removed from service following the reported event and repairs are pending with the customer.While on-site the technician counseled the user facility on the proper procedure for loading and unloading the sterilizer.No additional issues have been reported.

Event Description

The user facility reported that their evolution transfer carriage fell onto the docking station after placing a load into the sterilizer.No injury was reported.

Manufacturer Narrative

The transfer carriage was repaired, tested, and confirmed to operating according to specification.The transfer carriage was returned to service and no additional issues have been reported.

• Brand Name: 66" EVOLUTION TRANSFER CARRIAGE
• Type of Device: TRANSFER CARRIAGE TO STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• MDR Report Key: 8157431
• MDR Text Key: 130479394
• Report Number: 3005899764-2018-00108
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1