MAUDE Adverse Event Report: STERIS CANADA ULC THREE LEVEL MANIFOLD RACK TO WASHER

Device Problem Device Tipped Over (2589)

Patient Problem Insufficient Information (4580)

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the transfer cart and rack and found them to be operating according to specification; no repairs were required.Through follow up with user facility personnel, the technician learned that there was a rubber mat on the floor and the employee attempted to push the fully loaded transfer cart and rack over the mat.This caused the transfer cart to become unstable and fall to the floor allowing the manifold rack with instruments to contact the employee and for the reported event to occur.While onsite, the technician counseled user facility personnel on the proper use and operation of the transfer cart and manifold rack.No additional issues have been reported.

Event Description

The user facility reported that while operating their transfer cart, the fully loaded transfer cart including a manifold rack with instruments fell to the floor resulting in an injury.The user facility did not disclose if medical treatment was sought or administered.

Manufacturer Narrative

Through follow up with the user facility it was learned that the employee who was injured in the subject event did not receive medical treatment and returned to work.Through follow up it was also learned that the device subject of the reported event is a three level manifold rack - long.No additional issues have been reported.

• Brand Name: THREE LEVEL MANIFOLD RACK TO WASHER
• Type of Device: THREE LEVEL MANIFOLD RACK TO WASHER
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15677911
• MDR Text Key: 302726422
• Report Number: 9680353-2022-00027
• Device Sequence Number: 1
• Product Code: MEC
• 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,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• 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: 09/26/2022
• 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