MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the washer and found that the unit's incoming power terminal was damaged.Due to the damage, the part was not able to be further evaluated.Based on the technician's inspection, it is likely that the l2 incoming power terminal had a loose connection resulting in electrical arcing and causing the reported event to occur.The unit was installed in 2016 and is not under steris service agreement; the user facility is responsible for all maintenance activities.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specifications, and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that their reliance vision single chamber washer/disinfector was emitting smoke.No report of injury.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• 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: 11576710
• MDR Text Key: 243745873
• Report Number: 9680353-2021-00017
• 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
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• 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: 03/01/2021
• 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