MAUDE Adverse Event Report: STERIS CANADA CORPORATION HAMO RELIANCE VISION WASHER

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the hamo reliance vision washer and found the root cause of the reported event can be attributed to the drying elements within the washer.The drying elements overheated causing the reported event to occur.The washer was installed in december 2012 and is under steris service agreement for maintenance activities.The last maintenance was performed in september 2019.No issues with the function or operation of the washer were identified at this time.The unit was operating according to specification.The technician made the necessary repairs including replacing the unit's drying elements, ran a test cycle, and found the washer to be operating according to specification.No additional issues have been reported.

Event Description

The user facility reported smoke was coming from their hamo reliance vision washer.No report of flames.The building was evacuated, and the fire department was dispatched.No report of injury.

• Brand Name: HAMO RELIANCE VISION WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9504410
• MDR Text Key: 177390829
• Report Number: 9680353-2019-00053
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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: 11/22/2019
• 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