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

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 66" evolution transfer carriage and found that the locking pin was not at the proper height.If the locking pin is not at the proper height while loading and unloading, it may cause the transfer carriage to not properly engage with the docking station subsequently allowing the transfer carriage to fall to the floor.The root cause of the event was attributed to a loose nut and absence of threadlock subsequently allowing the locking pin to move to an improper height.The technician adjusted the locking pin to the proper height, tested the transfer carriage, confirmed it to be operating according to specification, and returned it to service.The unit was installed at the user facility in january 2018 and is currently under steris warranty.The transfer carriage was installed by a third-party service provider.Steris performed in-service training with the third-party service provider on the proper installation of the 66" evolution transfer carriage, specifically adjusting the locking pin.A 2-year complaint review indicates this to be an isolated event and no additional issues have been reported.

Event Description

The user facility reported that an employee was pulling their 66" evolution transfer carriage away from the sterilizer 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" EVOLUTION 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: 8165811
• MDR Text Key: 130636603
• Report Number: 3005899764-2018-00109
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• 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: 11/14/2018
• 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
• Patient Sequence Number: 1