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

Device Problems Unstable (1667); Device Fell (4014)

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

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the transfer carriage.The technician found that the transfer carriage did not properly engage with the docking station due to loose set screws in the roller bearing assembly inside the front leg and caster assembly.The technician tightened the set screws on the front leg and caster assembly to resolve the issue; however, this caused the trolley to bind when moved along the guide rails.The technician was unable to resolve the binding issue preventing the trolley from traversing the entire length of the carriage guide rails, therefore he recommended that the transfer carriage to be returned to steris for further evaluation.The transfer carriage is in the process of being shipped back to steris.A new unit was installed, and no additional issues have been reported.A follow-up mdr will be submitted should additional information become available.

Event Description

The user facility reported that an employee was unloading instruments with their 66" transfer carriage when the transfer carriage became unstable and fell to the floor.No report of injury.All instruments were reprocessed prior to use.

• 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: 8357582
• MDR Text Key: 139311965
• Report Number: 3005899764-2019-00015
• 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: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• 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: 01/25/2019
• 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