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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

On 1/7/2021, the user facility initially contacted steris and reported that one of their washers (s/n (b)(4)) was leaking water.The next day, a steris service technician arrived onsite to inspect the washer and spoke with user facility personnel who stated the leak was contained within the footprint of the unit.During his inspection, the technician found a broken weld on the leg pinning allowing water to leak.The technician repaired the weld, tested the unit, confirmed it to be operating according to specification, and returned it to service.In may 2021, the user facility contacted steris and reported a different washer (s/n (b)(4)) was leaking water from the lower leg pinning weld.The user facility reported that the leak was contained within the footprint of the unit.A steris service technician arrived onsite and made the necessary repairs to the unit.The technician tested the unit, confirmed it to be operating according to specification, and returned it to service.Following the reported leaks, steris evaluated the reported events and determined they did not meet the reporting criteria under 21 cfr part 803 as there was no potential for serious injury associated with the reported event.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures.No additional issues have been reported.

Event Description

The user facility reported via user facility medwatch report # (b)(4) that two of their reliance vision single chamber washer/disinfectors were leaking water.No report of injury.

• 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: 12109114
• MDR Text Key: 262231770
• Report Number: 9680353-2021-00030
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• 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