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

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and transfer carriage and identified there was a misalignment between the transfer carriage and sterilizer's docking station.As the latching mechanism on the front of the sterilizer was out of alignment, the employee attempted to forcefully pull the transfer carriage from the sterilizer's docking station causing the reported injury.The technician adjusted the transfer carriage to properly align with the sterilizer's docking station, tested the unit, and confirmed the equipment to be operating properly.No additional issues have been reported.

Event Description

The user facility reported that an employee experienced difficulty moving the transfer carriage when attempting to pull the transfer carriage away from the sterilizer causing the employee to strain their neck and shoulder.The employee sought medical treatment and returned to work.

• Brand Name: ATLAS 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: 7448042
• MDR Text Key: 106848552
• Report Number: 3005899764-2018-00026
• 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,Followup
• Report Date: 04/20/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 03/23/2018
• Supplement Dates FDA Received: 05/30/2018
• 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