MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 54" TRANSFER CARRIAGE TO STERILIZER

Device Problems Device Slipped (1584); Device Fell (4014)

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

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived to inspect the transfer carriage following the reported event.The technician was informed that while removing the loading car from 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 contacting the docking station.The instrument packs present were reprocessed prior to use in procedures.The technician identified that the front of the transfer carriage had been damaged upon contacting the docking station during the event and was unable to test the functionality of the transfer carriage.Based on the description of the event, it appears that the employee did not fully engage the transfer carriage to the sterilizer's docking station prior to loading the instruments into the sterilizer.The technician repaired the sterilizer's docking station and the transfer carriage, confirmed the unit to be operating according to specifications, and returned the unit to service.While onsite, the technician counseled the user facility on the proper procedure for loading and unloading the sterilizer, including ensuring the transfer carriage is properly engaged with docking station.No additional issues have been reported.

Event Description

The user facility reported that the front wheels on their 54" transfer carriage did not fully lock causing the loading car and transfer carriage to fall to the floor.No report of injury.

• Brand Name: 54" TRANSFER CARRIAGE TO STERILIZER
• 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: 8374906
• MDR Text Key: 138113629
• Report Number: 3005899764-2019-00018
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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: 01/31/2019
• 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