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

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 05/31/2022

Event Type  malfunction  

Event Description

The user facility reported an employee obtained an injury to their hand while operating the reliance vision single chamber washer/disinfector.Medical treatment was sought and administered.

Manufacturer Narrative

A steris service technician was onsite servicing another unit.While onsite, the user facility personnel told the technician that the washer door contacted the user's hand while trying to manually adjust an instrument that had obstructed the door, resulting in the reported event.As designed, the washer's safety bar was activated, and the washer's door raised in height upon contacting the employee's hand.The technician inspected the unit and found it to be operating according to specification, no repairs were required and the unit was returned to service.The reliance vision single-chamber washer/disinfector operator manual states (1-1), "warning - personal injury hazard: risk of pinch point between door and threshold when door opens.Keep fingers away from threshold." the operator manual further states (1-2), "warning - personal injury and/or equipment damage hazard: if an obstruction is present in the chamber door, obstruction sensor will detect obstruction and door will not close." the technician counseled the user facility personnel specifically on safe operating protocols.No additional issues have been reported.

• 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: 14884705
• MDR Text Key: 303706606
• Report Number: 9680353-2022-00020
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• 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: 06/02/2022
• 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