MAUDE Adverse Event Report: STERIS CANADA CORPORATION TRANSFER CART TO AMSCO 7053L WASHER/DISINFECTOR

Device Problems Component Falling (1105); Component Missing (2306)

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

Event Date 08/25/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The investigation of this event is currently in process.A follow up report will be submitted once additional information becomes available.

Event Description

The user facility reported while moving a loaded transfer cart a rack began to fall due to a missing stopper.An employee intervened to prevent the rack from falling and sustained a shoulder injury.

Manufacturer Narrative

The plastic black stopper was unable to be replaced.Therefore the transfer cart subject of the reported event was replaced.In-service training was completed with the user facility on (b)(4) 2015.

Manufacturer Narrative

A dta technician arrived onsite, inspected the unit, and identified a stopper was missing from the transfer cart.The transfer cart was removed from service.A replacement stopper was ordered and has been installed by the user facility.The user facility is responsible for maintenance of the unit.Section 1 of the operator manual for the amsco 7053l single-chamber washer/disinfector states, "incorrect rack loading/overloading could lead to injury and/or damage to the equipment or instruments." steris will conduct in-service training on the proper use and operation of the unit.

• Brand Name: TRANSFER CART TO AMSCO 7053L WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5098644
• MDR Text Key: 26787716
• Report Number: 9680353-2015-00059
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• 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?: No
• Date Manufacturer Received: 08/26/2015
• 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