MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS PASS-THRU

Model Number	1-2-610.003
Medical Device Problem Code	Filtration Problem (2941)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the filters of two advantage plus pass-thru units require replacement every 2-3 days.As a result, multiple patient procedures were postponed as the user facility did not have alternative reprocessing methods available.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and confirmed the micron filters were clogged.To resolve the issue, the user facility replaced the filters.The units were tested, confirmed to be operating according to specification, and returned to service.The technician collected water samples to test the facility's incoming water to ensure that their incoming water supply remains within the unit's operating requirements; results are pending.No additional issues have been reported.
Additional Manufacturer Narrative
Test results identified that one of the critical chemical attributes of water quality were above the maximum requirements.The advantage plus pass-thru instructions for use (ifu) states "potable water is the minimum standard, ro water is preferred.Steris recommends the use of a high quality water pre-filtration system that filters incoming water to 1 micron.The high performance 0.2 micron (absolute rated) water filters included with the reprocessor are highly effective at removing microorganisms and particles larger than 0.2 microns.Appropriate pre-filtration and regular disinfection are required to maintain the performance of this filter.The routine maintenance schedule recommends replacing the 0.2 micron water filter every six months or sooner, depending on the pre-filtration system and the quality of the incoming water.If the filter clogs to the point of noneffectiveness, the reprocessor will alarm and will not continue until the filter is replaced." the technician notified user facility personnel of the water quality test results and that their incoming water quality is not meeting the required operating conditions.The user facility has committed to making the necessary improvements to address their incoming water quality.No additional issues have been reported.

• Brand Name: ADVANTAGE PLUS PASS-THRU
• Common Device Name: ADVANTAGE PLUS PASS-THRU
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23498736
• Report Number: 2150060-2025-00035
• Device Sequence Number: 18390748
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: (01)00677964095832(11)240411
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1-2-610.003
• Device Catalogue Number: 12610003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown