MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 54" TRANSFER CARRIAGE; TRANSFER CARRIAGE TO THE STERILIZER

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived to inspect the transfer carriage following the reported event.The technician was informed that while unloading instruments from the sterilizer, the transfer carriage's front wheels did not lock into the sterilizer docking station; causing the front of the transfer carriage to fall to the floor.The instrument packs present on the loading cart did not contact the floor and did not require reprocessing.The technician identified that the front of the transfer carriage had been damaged upon contacting the floor during the event and was unable to test the functionality of the transfer carriage.Based on the description of the event, it appears that the employee did not fully engage the transfer carriage to the sterilizer's docking station prior to removing the rack from the sterilizer.The transfer carriage was removed from service following the reported event and a replacement transfer carriage was delivered to the user facility.No additional issues have been reported.A steris account manager is scheduled to perform in-service training on the proper procedure while loading and unloading the sterilizer on (b)(6) 2018.

Event Description

The user facility reported their 54" transfer carriage fell to the ground while an operator was removing a processed load from the sterilizer.No report of injury or procedure delay.

Manufacturer Narrative

On 1/24/2019, a steris account manager performed in-service training on the proper procedure for loading and unloading the sterilizer.No additional issues have been reported.

• Brand Name: 54" TRANSFER CARRIAGE
• Type of Device: TRANSFER CARRIAGE TO THE 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: 8139381
• MDR Text Key: 129591595
• Report Number: 3005899764-2018-00105
• 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: 12/06/2018

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: 11/07/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1