MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 60" TRANSFER CARRIAGE; TRANSFER CARRIAGE TO STERILIZER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the transfer carriage.While onsite, the technician was informed that while the employee was operating the transfer carriage, one of the wheels on the loading rack became unaligned with the track on the transfer carriage.The user tried to re-align the loading rack with the transfer carriage when her hand was pinched in-between the sterilizer door and the loading rack.The technician was able to identify the root cause of the event to be a broken wheel on the loading rack.While onsite the technician replaced all four wheels on the loading rack, tested the unit, and found it to be operating according to specification.This product was manufactured in 2009 and is not under steris service agreement for maintenance activity.No additional issues have been reported.

Event Description

The user facility reported that an employee injured their hand while operating a 60" transfer carriage.The employee sought medical treatment and returned to work.No procedure delay or cancellation was reported.

• Brand Name: 60" 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: 7659884
• MDR Text Key: 113284987
• Report Number: 3005899764-2018-00053
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• 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