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

Device Problem Device Fell (4014)

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

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

The instruments subject of the event did not contact the floor, therefore, did not require reprocessing.A steris service technician arrived onsite to inspect the transfer carriage and found that the latching rollers that allow the transfer carriage to engage with the docking station were not properly adjusted.The latching rollers were set too low and subsequently disengaged from the docking station causing the reported event to occur.The unit was installed in april 2019.The technician re-adjusted the latching rollers subject of the event including the facility's three additional units, tested the transfer carriages, confirmed them to be operating according to specification, and returned the units to service.The installation technician was retrained on proper installation activities for the 66" evolution transfer carriage.No additional issues have been reported.

Event Description

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

• Brand Name: 66" EVOLUTION TRANSFER CARRIAGE
• Type of Device: TRANSFER CARRIAGE
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8827472
• MDR Text Key: 164712930
• Report Number: 3005899764-2019-00068
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• 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: 06/26/2019
• 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