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

Device Problem Connection Problem (2900)

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

Event Date 08/12/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived on-site, inspected the unit, and identified that the front rail on the cart had been bent, causing the cart to not line up with the sterilizer inside rack.The technician repaired the rail, tested the unit, and confirmed it to be operating according to specification.The technician identified that the root cause of the incident was due to user facility personnel pushing the cart into the sterilizer with excessive force, causing front rail to be bent.The technician notified user facility personnel to use less force when pushing the cart into the sterilizer, and instructed them of the proper use and operation.No additional issues have been noted.

Event Description

The user facility reported that their 60" transfer cart was not locking into their sterilizer.No injury, procedural delay, or cancellation was reported.

• Brand Name: 66" 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5937169
• MDR Text Key: 54679452
• Report Number: 3005899764-2016-00064
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• 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: 08/12/2016
• 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