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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the atlas transfer carriage and found no issue with the function or operation of the carriage.No repairs were required and the carriage was returned to service.Through follow-up with facility personnel, the technician learned that facility personnel had not ensured that the loading car was properly engaged with the transfer carriage when unloading instruments from a previous cycle.As facility personnel subsequently utilized this loading car and transfer carriage to load instruments, the loading car slid off the transfer carriage and into the sterilizer.The employee attempted to move the loading car and subsequently hit the right side of their body on the transfer carriage causing the reported event to occur.The reported event is attributed to user error.The atlas transfer carriage operator manual states (1), "warning - prevent physical injury: always positively latch loading car to transfer carriage when car is outside sterilizer." the operator manual further states, "warning - prevent physical injury: get help if loading car becomes stuck or difficult to move.Do not attempt to lift a loading car without assistance." the technician counseled user facility personnel on proper use and operation of the atlas transfer carriage.No additional issues have been reported.

Event Description

The user facility reported that an employee was injured while operating their atlas transfer carriage.Medical treatment was sought.Facility personnel did not disclose if medical treatment was administered.

• Brand Name: ATLAS 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, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8634071
• MDR Text Key: 145934414
• Report Number: 3005899764-2019-00053
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• 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: 04/22/2019
• 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