MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 20" TRANSFER CART; TRANSFER CART TO AMSCO 400 STERILIZER

Device Problem Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 01/20/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician inspected the loading cart and found that the track inside the sterilizer was out of alignment.The technician adjusted the track and the height of the transfer cart and confirmed the sterilizer and transfer cart to be operating properly.No additional issues have been reported.The amsco 400 sterilizer was installed on (b)(4) 2014 and is serviced and maintained by the user facility.The transfer cart was installed and placed into serviced on 10/7/2015.The transfer cart is under steris warranty.

Event Description

The user facility reported that an employee cut their thumb while removing the loading cart from their amsco 400 sterilizer.In the process of removing the transfer cart from the sterilizer the cart became jammed.The employee pulled on the transfer cart with one hand and obtained a cut.The employee went to the facility's er and received stitches.

• Brand Name: 20" TRANSFER CART
• Type of Device: TRANSFER CART TO AMSCO 400 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5408435
• MDR Text Key: 37783726
• Report Number: 3005899764-2016-00007
• 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: 02/03/2016

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
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/03/2016
• 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