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

Device Problem Device Fell (4014)

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

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

All instruments subject to the reported event were reprocessed prior to use.A steris service technician arrived onsite following the reported event to inspect the 66" transfer carriage.The technician was informed that prior to his arrival, the user facility's biomed department had inspected the transfer carriage and found that the front bar on the transfer carriage had become damaged.The biomed department replaced the front bar and found the unit to be operational.The technician inspected the transfer carriage, tested the functionality, and found the unit to be operating according to specification.The root cause of the reported event can most likely be attributed to the transfer carriage not being properly locked into the sterilizer's docking station by user facility personnel.While onsite, the technician counseled user facility personnel on the proper use and maintenance of the transfer carriage specifically, ensuring the transfer carriage is properly locked into the docking station of the sterilizer.No additional issues have been reported.

Event Description

The user facility reported the front end of their 66" transfer carriage fell while unloading instruments from their evolution sterilizer.No report of injury or procedure delay.

• Brand Name: 66" TRANSFER CARRIAGE
• Type of Device: TRANSFER CARRIAGE
• 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: 8399504
• MDR Text Key: 138954137
• Report Number: 3005899764-2019-00020
• 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: 03/07/2019

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: 02/14/2019
• Initial Date FDA Received: 03/07/2019
• 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