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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the reliance vision single chamber washer and found that during the automated load process the rack was not completely inserted into the unit causing the door to become jammed.The technician learned that the employee was attempting to manually clear an obstruction when the door closed on their hand resulting in the reported event.The technician inspected the washer and found that the sensor on the steris conveyor system (scs) was misaligned and caused the rack to not be fully inserted in the washer during the automated loading process.Additionally, the door switch sensor had fallen out of place, causing the door not to retract.The reliance vision single-chamber washer/disinfector is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.The steris operator manual routine maintenance checklist states, "every 180 days, a door safety test is required to verify both doors security.While washer/ disinfector is in ready mode, an audible signal sounds and a message is displayed to remind the supervisor that the safety test must be performed.If the supervisor decides to bypass the safety test, the message pops up again after the following cycle.The message is displayed after each cycle until the safety test is performed.".The reliance vision single chamber washer operator manual states (1-1), "warning - personal injury hazard: risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." the operator manual further states (1-2), "warning.: if an obstruction is present in chamber door, do not attempt to remove the object.".The technician realigned the load door obstruction sensor on the scs and secured the door switch sensor back in its proper position, tested the unit, confirmed it to be operating according to specification, and returned to service.The technician conducted in-service training with the customer and their biomed personnel on following the routine maintenance checklist to ensure the unit's safety and to not free door obstruction manually.No additional issues have been reported.

Event Description

The user facility reported an employee obtained a cut on their hand while operating their reliance vision single chamber washer.The employee received stitches.

• 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: 15997082
• MDR Text Key: 308368019
• Report Number: 9680353-2022-00029
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 11/17/2022
• 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