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

Model Number	1-2-610.003
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the filters of two advantage plus pass-thru units clogged and gave a waterflow alarm.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
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and confirmed the filters were clogged.To resolve the issue, the technician replaced the filters.The unit was tested, confirmed to be operating according to specification, and returned to service.The filters subject of the reported event were returned to steris for evaluation.No issues were noted with the functionality of the filters.The advantage plus pass-thru 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." water samples from the user facility were collected and revealed the presence of sediment, which could shorten the service life of the filters.The technician notified user facility personnel of the water quality test results and that their water quality is not meeting the required operating conditions.The user facility has committed to making the necessary improvements to the facility's incoming water quality.No additional issues have been reported.

• Brand Name: ADVANTAGE PLUS PASS-THRU
• Common Device Name: ADVANTAGE PLUS
• 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
• MDR Report Key: 21337340
• Report Number: 2150060-2025-00005
• Device Sequence Number: 3826650
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: (01)00677964095832(11)240411(01)00677964095832(11)240412(21)13145843
• 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): 02/07/2025

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
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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