MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM

Model Number	1-2-510.003
Medical Device Problem Code	Filtration Problem (2941)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon further investigation, it was learned that the low flow alarm alerted personnel that the advantage plus endoscope reprocessing systems were not working properly during a cycle due to the micron filter needing replaced.The serial numbers for the units subject of the event are (b)(6).User facility biomed replaced the micron filters, ran test cycles, confirmed the units to be operating according to specification, and returned them to service.The advantage plus endoscope reprocessing system instructions for use states, "potable water is the minimum standard for a facility water supply.Water that has been purified by a reverse osmosis system is preferred.When properly maintained, the water line filtration system will filter particles that are larger than 0.1 microns from the facility water supply.The routine maintenance schedule recommends replacing the 0.1 micron water filter every six months or sooner.Depending on the facility water quality, the water filters may need to be replaced on a more frequent basis.If the filter clogs to the point of noneffectiveness, the reprocessor will alarm and will not continue until the filter is replaced." a steris quality specialist counseled user facility personnel on the proper use and operation of the advantage plus endoscope reprocessing system, specifically to regularly replace the micron filter as recommended per the instructions for use.No additional issues have been reported.
Event or Problem Description
The user facility reported that three of their advantage plus endoscope reprocessing systems were not working properly.Because the facility had no other available methods of reprocessing devices, procedures were postponed.No report of injury.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: ENDOSCOPE REPROCESSING SYSTEM
• 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: 24402043
• Report Number: 2150060-2026-00006
• Device Sequence Number: 9905038
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: (01)00677964044755(11)130611
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102996
• 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
• Report Date (Section B): 02/20/2026

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: 1-2-510.003
• Device Catalogue Number: ADV12510003
• 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: 01/21/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2013
• 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