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

Device Problem Unstable (1667)

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

Event Date 09/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived on-site, inspected the unit, and identified a missing wheel caster, causing the transfer carriage to become unstable.The technician replaced the wheel caster, tested the unit and confirmed it to be operating according to specification.The technician identified the missing caster was caused by improper installation of the wheel caster by steris personnel.The technician found that excessive torque was applied to the wheel caster, which caused it to fall off after usage.The unit is under steris contract for warranty.The district service manager will perform re-training with the steris personnel responsible for the installation of the wheel caster.No additional issues have been reported.

Event Description

The user facility reported that their atlas transfer carriage was unstable.No injury, procedural delay, or cancellation was reported.

• Brand Name: ATLAS 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6030698
• MDR Text Key: 57807966
• Report Number: 3005899764-2016-00074
• 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: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• 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
• Date Manufacturer Received: 09/16/2016
• 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