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

Device Problem Component Falling (1105)

Patient Problems Pain (1994); Neck Pain (2433)

Event Date 04/17/2018

Event Type  Malfunction  

Manufacturer Narrative

A steris service technician arrived at the facility following the event to inspect the transfer carriage and sterilizer. While onsite, the technician reviewed facility video footage of the event which indicates the operator attempted to latch the transfer carriage to the sterilizer with excessive force; resulting in damage to the cart's docking station. Additionally, the operator did not check that the front wheel assembly of the transfer carriage was properly latched to the docking station before withdrawing the cart from the sterilizer. The items which were removed from the sterilizer at the time of the event did not contact the floor and did not require reprocessing. The technician replaced the docking station's latching mechanism, successfully docked and undocked the transfer carriage from the sterilizer and returned the unit to service. While onsite the technician verified that all other transfer carriages located at the facility properly docked and undocked from the sterilizer(s) and did not require adjustment. The technician performed in-service training on the proper procedures for docking the transfer carriage to the sterilizer prior to removing a processed load. No additional issues have been reported.

Event Description

The user facility reported their 66" transfer carriage fell to the ground while an operator was removing a processed load from the sterilizer. Following the event, the operator sought medical treatment for reported neck and back pain. No injuries were evident at the time of the evaluation and the employee was advised to a week of light work duty. The employee has since returned to full work duties.

• Brand Name: 66" 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
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7522411
• MDR Text Key: 108987535
• Report Number: 3005899764-2018-00030
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (Y/N): N
• Reporter Country Code: CA
• 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: 05/17/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/17/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/17/2018
• 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