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

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Burn, Thermal (2530)

Event Date 03/03/2019

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the employee was unloading instruments when one of the wheels fell off the transfer carriage subsequently causing the reported event to occur.The instrument packs present on the loading car did not contact the floor and did not require reprocessing.A steris service technician arrived onsite to inspect the transfer carriage and found that the bolt that secures the wheel in place had become loose subsequently allowing the wheel to fall off.The technician performed the necessary repairs to reattach the wheel, tested the unit, confirmed it to be operating according to specification, and returned it to service.The unit was manufactured in 2010 and is approximately 9 years old.The transfer carriage and loading car are not under a steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.No additional issues have been reported.

Event Description

The user facility reported that a wheel fell off their atlas transfer carriage causing the transfer carriage to fall to the floor.In the process an employee obtained a burn on their bicep.The user facility did not disclose if medical treatment was sought or administered.No report of procedure delay.

• Brand Name: TRANSFER CARRIAGE TO STERILIZER
• Type of Device: TRANSFER CARRIAGE
• 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: 8457523
• MDR Text Key: 140153385
• Report Number: 3005899764-2019-00029
• 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
• Report Date: 03/27/2019

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: 03/04/2019
• Initial Date FDA Received: 03/27/2019
• 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