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

Device Problem Device Fell (4014)

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

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the transfer carriage following the reported event.The technician was informed that after an employee loaded instruments into the sterilizer, the transfer carriage's front wheels were not fully locked into the sterilizer docking station; causing the front of the transfer carriage to fall to the floor.The instrument packs were not affected as they were loaded into the sterilizer prior to the subject event.The technician inspected the transfer carriage and loading car and was unable duplicate the reported event; no repairs were required.The reported event can be attributed to user error as the employee did not fully engage the transfer carriage to the sterilizer's docking station.While onsite, the technician counseled user facility personnel on the proper procedure for loading and unloading the sterilizer.No additional issues were reported.

Event Description

The user facility reported that after loading the sterilizer their 66" evolution transfer carriage fell to the floor.No injuries were associated with the reported event.

• Brand Name: 66" EVOLUTION 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: 8527287
• MDR Text Key: 142532376
• Report Number: 3005899764-2019-00040
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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
• Date Manufacturer Received: 03/20/2019
• 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