MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE 444 WASHER/DISINFECTOR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Abrasion (1689)

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the reliance 444 washer/disinfector and found that the door cable was misaligned with the door pulley.As the door cable was misaligned, the door fell and contacted the employee's hand resulting in the reported event.The misalignment of the door cable may have been attributed to a previous obstruction in the doorway.The reliance 444 washer/disinfector operator manual states (1-1), "warning-personal injury hazard: if an obstruction is present in the wash chamber door and door is unable to raise, do not attempt to remove obstruction from under the door.Door cables may have slackened and door may close at high speed when obstruction is removed.Call a qualified service technician to safely remove obstruction." the technician counseled user facility personnel on the proper use and operation of the reliance 444 washer/disinfector.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained abrasions to their hand while loading a manifold rack into their reliance 444 washer/disinfector.Medical treatment was sought and administered.

• Brand Name: RELIANCE 444 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: 16385070
• MDR Text Key: 309650714
• Report Number: 9680353-2023-00006
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• 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: 01/19/2023
• 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