MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 7053L SINGLE CHAMBER WASHER

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/31/2014

Event Type  No Answer Provided  

Event Description

The customer expressed dissatisfaction with the conveyor systems and transfer cart accessories that are utilized with their amsco 7053l single chamber washers.No injuries have been reported.

Manufacturer Narrative

Investigation of the event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

The user facility reported an operator was moving a loading cart and while turning a corner the rack rolled off the cart.No injuries occurred.A steris service technician inspected the transfer cart accessories and found that the rack stoppers required replacement.The technician repaired the transfer carts and returned them to service.No additional issues have been reported.

• Brand Name: AMSCO 7053L SINGLE CHAMBER WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4470510
• MDR Text Key: 5318822
• Report Number: 9680353-2015-00012
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• 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?: Yes
• Date Manufacturer Received: 12/31/2014
• 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