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

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived onsite and found that the stainless steel cover plate on the docking station sustained damage due to the impact of the load and carriage falling.An employee at the user facility stated that the cause of the reported event may have been attributed to improper unloading by the employee subject of the reported event.It is believed that the employee pulled the transfer carriage out too quickly from the docking station or the locking pins were not properly seated.The steris service technician advised user facility personnel of the proper use and operation of the transfer carriage.The transfer carriage and sterilizer are not under steris service contract and are serviced and maintained by the user facility.User facility personnel made the proper repairs and returned the units to service.No additional issues have been reported.

Event Description

The user facility reported that an employee was unloading the sterilizer via the transfer carriage when the load fell off the carriage and the carriage fell to the ground.No report of injury.

• Brand Name: 66" EVOLUTION 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: 5246884
• MDR Text Key: 32065946
• Report Number: 3005899764-2015-00081
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/24/2015
• 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