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

Device Problem Smoking (1585)

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

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation of this event is in process.The unit subject of the event is serviced and maintained by a third party; steris has requested access to the unit and any parts that have been replaced in order to conduct a full evaluation.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that the recirculation pump of their reliance vision multi-chamber washer/disinfector overheated, and a small amount of smoke was observed.No report of injury.

Manufacturer Narrative

Steris service requested access to the reliance vision multi-chamber washer/disinfector subject of the reported event however, the facility's third-party service provider had removed all damaged components prior to the steris service technicians inspection.Steris requested the components be sent back for evaluation however, the components have not been returned.Without the return of the components for evaluation, a root cause cannot be determined.Following the reported event, the steris service technician made repairs to the reliance vision multi-chamber washer/disinfector, tested the function and operation of the unit, and returned it to service.No additional issues have been reported.

• Brand Name: RELIANCE VISION MULTI-CHAMBER WASHER/DISINFECTOR
• Type of Device: 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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 17325559
• MDR Text Key: 319069954
• Report Number: 9680353-2023-00026
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• 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