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

Model Number Single Chamber

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician inspected the reliance vision-single chamber washer/disinfector and found no issues with the function or operation of the device.No issues were noted with the unit's door safety switches on the loading and unloading doors.The technician tested the washer/disinfector and returned the unit to service.The reliance vision single chamber washer operator manual states (1-2), "if an obstruction is present in chamber door, do not attempt to remove the object." the technician counseled user facility personnel on the proper use and operation of the reliance vision-single chamber washer/disinfector, specifically on safe operating protocols.No additional issues have been reported.

Event Description

The user facility reported that an employee was manually removing an obstruction from their reliance vision-single chamber washer/disinfector when the chamber door came down and contacted the employee's hand; the employee obtained a cut.The employee sought and received medical treatment.

• 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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16727201
• MDR Text Key: 313196326
• Report Number: 9680353-2023-00010
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995192655
• UDI-Public: 00724995192655
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Single Chamber
• Device Catalogue Number: FH05043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• 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