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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the employee was manually attempting to free an obstruction by pushing the basket into the washer's chamber.When the basket was pushed into the washer chamber and the obstruction was cleared, the washer door lowered down and contacted the employee's hand/wrist.A steris service technician inspected the reliance vision multi-chamber washer/disinfector and found no issues with the function or operation.The employee subject of the reported event did not follow proper operating procedures for clearing an obstruction.The operator manual states, "if an obstruction is present in a chamber door, do not attempt to remove the object.A door obstruction sensor detects the obstruction.Door automatically stops from closing and remains open at any height.(.) 6.If operator is unable to remove obstruction from chamber door, call a qualified service technician." user facility personnel were counseled on the proper use and operation for the reliance vision multi-chamber washer/disinfector specifically the importance of following proper obstruction procedures.The steris service technician returned the unit to service and no additional issues have been reported.

Event Description

The user facility reported than an employee obtained an injury to their hand/wrist while trying to remove an obstruction between the reliance vision multi-chamber washer/disinfector's door and safety bar.Medical treatment was sought and administered.

• Brand Name: RELIANCE VISION MULTI-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: 17835844
• MDR Text Key: 324501260
• Report Number: 9680353-2023-00035
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/28/2023
• 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