MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 5052 WASHER

Device Problems Fire (1245); Noise, Audible (3273)

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

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that their amsco 5052 washer made a loud noise and a small flame was observed inside the unit.No report of injury.No evacuations occurred; the flame quickly went out on its own.

Manufacturer Narrative

A steris service technician arrived on site following the reported event to inspect the amsco 5052 washer.No injury or procedure delays were reported.The technician inspected the unit and found that the drying manifold, contactor, and control box assembly required replacement.Due to the damage sustained, the unit was removed from service and the parts were returned to steris for further evaluation.Steris engineering attempted to examine the returned components however, they were too damaged to perform a proper evaluation.A two-year complaint review indicates this to be an isolated event.The amsco 5052 washer was repaired and returned to service.No additional issues have been reported.

• Brand Name: AMSCO 5052 WASHER
• Type of Device: WASHER
• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8187230
• MDR Text Key: 131339385
• Report Number: 9680353-2018-00093
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 12/04/2018
• 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